Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Gallium-68 NODAGA-LM3 PET/CT; Gallium-68 DOTA-LM3 PET/CT; Gallium-68 DOTATATE PET/CT
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic