Status:
COMPLETED
Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 dete...
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04318561
Start Date
December 1 2019
End Date
December 1 2021
Last Update
December 21 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730