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Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

Primary Purpose

Prostate Cancer, Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Intravenous injection of [99mTc]Tc-DB8
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Breast cancer, Gastrin releasing peptide receptors, [99mTc]Tc-DB8, SPECT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is > 18 years of age Clinical and radiological diagnosis of prostate cancer and breast cancer with histological verification. White blood cell count: > 2.0 x 10^9/L Haemoglobin: > 80 g/L Platelets: > 50.0 x 10^9/L Bilirubin =< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits Blood glucose level not more than 5.9 mmol/L A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: Active current autoimmune disease or history of autoimmune disease Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) Known HIV positive or chronically active hepatitis B or C Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sites / Locations

  • TomskNRMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prostate cancer

Breast cancer

Arm Description

At least five (5) evaluable subjects with prostate cancer

At least five (5) evaluable subjects with breast cancer

Outcomes

Primary Outcome Measures

Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)
Whole-body [99mTc]Tc-DB8 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
SPECT-based [99mTc]Tc-DB8 value in tumor lesions (counts)
[99mTc]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-DB8 background uptake value (counts)
Focal uptake of [99mTc]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-DB8 uptake coinciding with the regions without pathological findings (counts)

Secondary Outcome Measures

Safety attributable to [99mTc]Tc-DB8 injections (physical findings)
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline).
Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline).
Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).
Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).

Full Information

First Posted
July 4, 2023
Last Updated
July 4, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05940298
Brief Title
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8
Official Title
SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborators
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The primary objective are: To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals. To evaluate dosimetry of [99mTc]Tc- DB8. To study the safety and tolerability of the drug [99mTc]Tc- DB8 after a single injection in a diagnostic dosage. The secondary objective are: 1. To compare the obtained [99mTc]Tc- DB8 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and breast cancer patients.
Detailed Description
The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled DB8. Phase I of the study: Biodistribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The main objectives of the study: To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. To evaluate dosimetry of 99mTc-DB8 based on the pharmacokinetic parameters of the drug after a single intravenous administration. To study the safety of use and tolerability of the drug 99mTc-DB8 after a single intravenous administration in a diagnostic dosage. Additional research tasks: 1. To conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer and breast cancer by SPECT using 99mTc-DB8 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material. Methodology: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Breast Cancer
Keywords
Prostate cancer, Breast cancer, Gastrin releasing peptide receptors, [99mTc]Tc-DB8, SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate cancer
Arm Type
Experimental
Arm Description
At least five (5) evaluable subjects with prostate cancer
Arm Title
Breast cancer
Arm Type
Experimental
Arm Description
At least five (5) evaluable subjects with breast cancer
Intervention Type
Drug
Intervention Name(s)
Intravenous injection of [99mTc]Tc-DB8
Other Intervention Name(s)
[99mTc]Tc-DB8
Intervention Description
One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Primary Outcome Measure Information:
Title
Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)
Description
Whole-body [99mTc]Tc-DB8 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
Time Frame
24 hours
Title
SPECT-based [99mTc]Tc-DB8 value in tumor lesions (counts)
Description
[99mTc]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Time Frame
6 hours
Title
SPECT-based [99mTc]Tc-DB8 background uptake value (counts)
Description
Focal uptake of [99mTc]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts
Time Frame
6 hours
Title
Tumor-to-background ratio (SPECT)
Description
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-DB8 uptake coinciding with the regions without pathological findings (counts)
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Safety attributable to [99mTc]Tc-DB8 injections (physical findings)
Description
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline).
Time Frame
24 hours
Title
Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)
Description
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline).
Time Frame
24 hors
Title
Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)
Description
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).
Time Frame
24 hours
Title
Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)
Description
The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is > 18 years of age Clinical and radiological diagnosis of prostate cancer and breast cancer with histological verification. White blood cell count: > 2.0 x 10^9/L Haemoglobin: > 80 g/L Platelets: > 50.0 x 10^9/L Bilirubin =< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits Blood glucose level not more than 5.9 mmol/L A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: Active current autoimmune disease or history of autoimmune disease Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) Known HIV positive or chronically active hepatitis B or C Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir I Chernov, MD,Prof
Phone
+73822426284
Email
chernov@tnimc.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasiy N Rybina, MD,PhD
Phone
+73822426284
Email
pankovaan@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir I Chernov, MD,Prof
Organizational Affiliation
TomskNRMC Tomsk, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
TomskNRMC
City
Tomsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir I Chernov, MD, Prof.
Phone
+7-3822-426284
Email
chernov@tnimc.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

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