Back to resultsGallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors (PET)
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gallium-68 NODAGA-LM3 PET/CT
Gallium-68 DOTA-LM3 PET/CT
Gallium-68 DOTATATE PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- Written informed consent.
- Patients of either gender, aged ≥ 18 years.
- Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor.
- A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available.
- At least 1 measurable lesion based on RECIST v1.1.
- Blood test results as follows (White blood cell: ≥ 3*10^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN)
- Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.
- Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.
Exclusion Criteria:
- Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to TATE or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3 or Gallium-68 DOTATATE.
- Presence of active infection at screening or history of serious infection within the previous 6 weeks.
- Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug.
- Any neuroendocrine tumor-specific treatment between antagonist and agonist scans.
- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
- Pregnant or breast-feeding women.
- Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of > 5 years can be included.
- Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gallium-68 NODAGA-LM3 group
Gallium-68 DOTA-LM3 group
Arm Description
Patients will undergo a Gallium-68 NODAGA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
Patients will undergo a Gallium-68 DOTA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
Outcomes
Primary Outcome Measures
Blood pressure[Safety and tolerability]
Measured in millimetre of mercury.
Heart rate[Safety and tolerability]
Measured in beats per minute.
Pulse oximetry[Safety and tolerability]
Measured in percentage.
Electrocardiogram QT interval[Safety and tolerability]
3-lead electrocardiogram
Incidence of adverse effect[Safety and tolerability]
According to version 4.03 of the Common Terminology Criteria for Adverse Events.
Secondary Outcome Measures
Cmax (maximum concentration achieved in units of Bq/ml)
Determination of Cmax for target lesion and discernible organs
Tmax (time to achieve Cmax)
Determination of Tmax for target lesion and discernible organs.
Standard uptake value (SUV)
Determination of SUV for detected lesions and discernible organs of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
Lesion numbers
Determination of lesion numbers of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
Full Information
NCT ID
NCT04318561
First Posted
March 18, 2020
Last Updated
December 20, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04318561
Brief Title
Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
Acronym
PET
Official Title
A Prospective, Randomized, Double-blinded Study to Evaluate the Safety, Biodistribution, Dosimetry and Lesion Detection Ability of Gallium-68 Labeled LM3 for the Diagnostic Imaging of Metastatic, Well-differentiated Neuroendocrine Tumors Using PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
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
LM3 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist, This study is to evaluate the safety, biodistribution, dosimetry, and lesion detection ability of Gallium-68 labeled somatostatin receptor antagonist LM3 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT).
The results will be compared between antagonist Gallium-68 labeled LM3 and agonist Gallium-labeled DOTATATE in the same group of patients.
It will also be compared between the two different antagonists, Gallium-68 DOTA-LM3 and Gallium-68 NODAGA-LM3, in two parallel-designed arms.
Detailed Description
Patients with histologically confirmed metastatic, well-differentiated neuroendocrine tumors will be recruited in this study.
All patients will be randomized into two groups: Gallium-68 NODAGA-LM3 group and Gallium-68 DOTA-LM3 group.
The study will be divided into the following 2 parts:
Part ONE, which will enroll 16 patients (8 in each group), focuses on the safety evaluation, biodistribution, and dosimetry. In Part A, patients will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3 or Gallium-68 DOTA-LM3 (according to their group).
Part TWO, which will enroll 24 patients (12 in each group) and follows Part A study, focuses on lesion detection ability. In Part B, patients will undergo one whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3 or Gallium-68 DOTA-LM3 (according to their group).
All patients need to do a Gallium-68 DOTATATE PET/CT scan (40ug/150-200MBq, 1h post-injection) for comparison on the next day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The details of patient groups will be sealed in sequentially numbered, opaque, sealed envelopes generated by Xuezhu Wang from the nuclear medicine department, Peking Union Medical College Hospital, who will not participate in other parts of the study.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gallium-68 NODAGA-LM3 group
Arm Type
Experimental
Arm Description
Patients will undergo a Gallium-68 NODAGA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
Arm Title
Gallium-68 DOTA-LM3 group
Arm Type
Experimental
Arm Description
Patients will undergo a Gallium-68 DOTA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gallium-68 NODAGA-LM3 PET/CT
Intervention Description
Twenty patients will take this intervention. They will be further divided into two sub-groups with the same interventional radiopharmaceutical (Gallium-68 NODAGA-LM3) but different scanning protocols (Protocol A and Protocol B). The first enrolled 8 patients will go with Protocol A, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol B, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gallium-68 DOTA-LM3 PET/CT
Intervention Description
Twenty patients will take this intervention. They will be further divided into two sub-groups with the same intervention radiopharmaceutical (Gallium-68 DOTA-LM3) but different scanning protocols (Protocol C and Protocol D). The first enrolled 8 patients will go with Protocol C, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 DOTA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol D, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 DOTA-LM3.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gallium-68 DOTATATE PET/CT
Intervention Description
All patients have to do a Gallium-68 DOTATATE PET/CT scan (40ug/150-200MBq, 1h post-injection) for comparison on the next day of LM3 scan. Safety assessment and tolerability of the previous LM3 study will be conducted right before the study.
Primary Outcome Measure Information:
Title
Blood pressure[Safety and tolerability]
Description
Measured in millimetre of mercury.
Time Frame
Within 1 hour prior to the administration of radiopharmaceuticals.
Title
Heart rate[Safety and tolerability]
Description
Measured in beats per minute.
Time Frame
Within 1 hour prior to the administration of radiopharmaceuticals.
Title
Pulse oximetry[Safety and tolerability]
Description
Measured in percentage.
Time Frame
Within 1 hour prior to the administration of radiopharmaceuticals.
Title
Electrocardiogram QT interval[Safety and tolerability]
Description
3-lead electrocardiogram
Time Frame
Within 1 hour prior to the administration of radiopharmaceuticals.
Title
Incidence of adverse effect[Safety and tolerability]
Description
According to version 4.03 of the Common Terminology Criteria for Adverse Events.
Time Frame
From right after tracer injection to 24-hours post-injection
Secondary Outcome Measure Information:
Title
Cmax (maximum concentration achieved in units of Bq/ml)
Description
Determination of Cmax for target lesion and discernible organs
Time Frame
From right after tracer injection to 2-hours post-injection
Title
Tmax (time to achieve Cmax)
Description
Determination of Tmax for target lesion and discernible organs.
Time Frame
From right after tracer injection to 2-hours post-injection
Title
Standard uptake value (SUV)
Description
Determination of SUV for detected lesions and discernible organs of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
Time Frame
From right after tracer injection to 2-hours post-injection
Title
Lesion numbers
Description
Determination of lesion numbers of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
Time Frame
From right after tracer injection to 2-hours post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent.
Patients of either gender, aged ≥ 18 years.
Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor.
A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available.
At least 1 measurable lesion based on RECIST v1.1.
Blood test results as follows (White blood cell: ≥ 3*10^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN)
Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.
Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.
Exclusion Criteria:
Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to TATE or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3 or Gallium-68 DOTATATE.
Presence of active infection at screening or history of serious infection within the previous 6 weeks.
Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug.
Any neuroendocrine tumor-specific treatment between antagonist and agonist scans.
Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
Pregnant or breast-feeding women.
Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of > 5 years can be included.
Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjia Zhu, MD
Organizational Affiliation
Peking Uion Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34874478
Citation
Zhu W, Jia R, Yang Q, Cheng Y, Zhao H, Bai C, Xu J, Yao S, Huo L. A prospective randomized, double-blind study to evaluate the diagnostic efficacy of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with 68Ga-DOTATATE. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1613-1622. doi: 10.1007/s00259-021-05512-y. Epub 2021 Dec 7.
Results Reference
derived
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Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
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