Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

October 29, 2019

Study Completion Date

October 29, 2019

Conditions
Neuroendocrine Tumors
Interventions
DRUG

Al18F-NOTA-octreotide

One intravenous injection of 4 MBq/kg

DEVICE

PET/CT

"Part 1: Healthy volunteers will undergo consecutive whole-body PET scans, including one low-dose CT, for the first 90 minutes. At 150 ± 15 min and 300 ± 30 min post injection two additional static whole-body PET/CT scans will be acquired.~Part 2: Neuroendocrine tumor patients will undergo a dynamic PET scan for the first 45 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection."

OTHER

Venous blood samples

Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements (only for patients) at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).

Trial Locations (1)

3000

Universitaire Ziekenhuizen Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT03883776 - Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors | Biotech Hunter | Biotech Hunter