Back to results[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) (NeoFIND)
Primary Purpose
Breast Cancer, Prostate Cancer, Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
[68Ga]-NeoBOMB1
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring [68Ga]-NeoBOMB1
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age
- Subjects must have signed and dated an informed consent prior to any study-specific procedures
- Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
- Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate
- Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
- At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to [68Ga]-NeoBOMB1 administration
- The Eastern Cooperative Oncology (ECOG) performance status 0-2.
- Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.
Exclusion Criteria:
- renal insufficiency or an eGFR <50 ml/min/1.73m2
- hematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
- participation in any other investigational trial within 30 days of study entry
- subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
- concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
- concurrent bladder outflow obstruction or unmanageable urinary incontinence
- known or expected hypersensitivity to [68Ga]-NeoBOMB1 or any excipient present in [68Ga]-NeoBOMB1
- any condition that precludes raised arms position
- prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
- history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Sites / Locations
- Medical University Innsbruck Department of Nuclear Medicine
- University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire
- University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase II dosimetry group
Phase II non-dosimetry group
Arm Description
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Outcomes
Primary Outcome Measures
Number of Lesions Detected by [68Ga]-NeoBOMB1
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
Secondary Outcome Measures
Treatment Emergent Adverse Events Profile
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of [68Ga]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Number of Lesions Detected by Conventional Imaging
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Number of Participants With Lesions Detected by Conventional Imaging Per Location
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. The location of lesions identified by aforementioned PET imaging were to be compared with the location of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
At lesion level, overall, positive, and negative agreement of [68Ga]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows:
Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg
Positive agreement = 100% x Double positive / (Double positive + Comparator single positive)
Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1.
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
The diagnostic performance of [68Ga]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens.
Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on [68Ga]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on [68Ga]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).
Dosimetry Group: Absorbed Dose in Target Organs
The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.
Dosimetry Group: Effective Whole-body Dose
The effective radiation dose was to be summarized with descriptive statistics.
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. The half-lives of distribution (T^1/2 alpha) and elimination phases (T^1/2 beta) were to be listed and summarized using descriptive statistics.
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Cmax was to be listed and summarized using descriptive statistics.
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t) was to be listed and summarized using descriptive statistics.
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t)/D was to be listed and summarized using descriptive statistics.
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-inf) was to be listed and summarized using descriptive statistics.
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. CL was to be listed and summarized using descriptive statistics.
Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd was to be listed and summarized using descriptive statistics.
Full Information
NCT ID
NCT03724253
First Posted
October 21, 2018
Last Updated
October 22, 2020
Sponsor
Advanced Accelerator Applications
1. Study Identification
Unique Protocol Identification Number
NCT03724253
Brief Title
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
Acronym
NeoFIND
Official Title
Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was stopped before the target sample size was achieved.
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
July 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Accelerator Applications
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).
Detailed Description
A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Keywords
[68Ga]-NeoBOMB1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study design included a dosimetry and non-dosimetry groups and with the following tumor types:
Breast Cancer: dosimetry and non-dosimetry groups
Prostate Cancer: dosimetry and non-dosimetry groups
Colorectal cancer: non-dosimetry group
Non-Small Cell Lung Cancer (NSCLC): non-dosimetry group
Small-Cell Lung Cancer (SCLC): non-dosimetry group All data presentations were to be presented primarily by the overall population but were also to be repeated split by tumor type where relevant. Some presentations were also to be repeated split by whether or not the patient was found to have tumors bearing GRPR expression according to cytology and/or histopathology findings.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase II dosimetry group
Arm Type
Experimental
Arm Description
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Arm Title
Phase II non-dosimetry group
Arm Type
Experimental
Arm Description
All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Intervention Type
Drug
Intervention Name(s)
[68Ga]-NeoBOMB1
Intervention Description
[68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
Primary Outcome Measure Information:
Title
Number of Lesions Detected by [68Ga]-NeoBOMB1
Description
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
Description
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Description
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
Title
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Description
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
Title
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Description
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Title
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Description
Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Title
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
Description
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Title
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
Description
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Secondary Outcome Measure Information:
Title
Treatment Emergent Adverse Events Profile
Description
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of [68Ga]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time Frame
From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
Title
Number of Lesions Detected by Conventional Imaging
Description
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Number of Participants With Lesions Detected by Conventional Imaging Per Location
Description
The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. The location of lesions identified by aforementioned PET imaging were to be compared with the location of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
Description
At lesion level, overall, positive, and negative agreement of [68Ga]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows:
Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg
Positive agreement = 100% x Double positive / (Double positive + Comparator single positive)
Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
Time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
Description
At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1.
Time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
Description
The diagnostic performance of [68Ga]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens.
Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on [68Ga]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on [68Ga]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).
Time Frame
Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Absorbed Dose in Target Organs
Description
The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Effective Whole-body Dose
Description
The effective radiation dose was to be summarized with descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. The half-lives of distribution (T^1/2 alpha) and elimination phases (T^1/2 beta) were to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Cmax was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t) was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t)/D was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-inf) was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
Description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. CL was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Title
Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
Description
Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd was to be listed and summarized using descriptive statistics.
Time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 18 years of age
Subjects must have signed and dated an informed consent prior to any study-specific procedures
Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate
Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to [68Ga]-NeoBOMB1 administration
The Eastern Cooperative Oncology (ECOG) performance status 0-2.
Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.
Exclusion Criteria:
renal insufficiency or an eGFR <50 ml/min/1.73m2
hematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
participation in any other investigational trial within 30 days of study entry
subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
concurrent bladder outflow obstruction or unmanageable urinary incontinence
known or expected hypersensitivity to [68Ga]-NeoBOMB1 or any excipient present in [68Ga]-NeoBOMB1
any condition that precludes raised arms position
prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Innsbruck Department of Nuclear Medicine
City
Innsbruck
Country
Austria
Facility Name
University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire
City
La Tronche
Country
France
Facility Name
University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan
City
Pessac
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
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