Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors

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.

Conditions

• Neuroendocrine Tumors

Interventions

DIAGNOSTIC_TEST

Gallium-68 NODAGA-LM3 PET/CT

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.

DIAGNOSTIC_TEST

Gallium-68 DOTA-LM3 PET/CT

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.

DIAGNOSTIC_TEST

Gallium-68 DOTATATE PET/CT

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Wenjia Zhu, MD · Peking Uion Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2021-12-01

Completion

2021-12-01

Countries

• China

Study Locations