Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes 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.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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, wh...
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.
Tracking Information
- NCT #
- NCT04318561
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Wenjia Zhu, MD Peking Uion Medical College Hospital
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