Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2019

Primary Completion Date

December 1, 2021

Study Completion Date

December 1, 2021

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.

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER

NCT04318561 - Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors | Biotech Hunter | Biotech Hunter