NCT03883776

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

Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.

Detailed description

In the first part of the study, six healthy volunteers will undergo several sequential whole-body PET/CT scans starting from the moment of tracer injection up to six hours post injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in humans. In the second part of the study, six neuroendocrine tumor patients, with at least five positive lesions on routine clinical 68Ga-DOTA-peptide PET, will undergo a dynamic PET scan for the first 45 minutes, followed by three single static whole-body PET/CTs up to three hours post injection for an initial efficacy assessment (evaluation of the lesion detection rate) and pharmacokinetics study of Al18F-NOTA-octreotide in humans. Furthermore a first comparison with 68Ga-DOTA peptide PET will be performed.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-04-11
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2019-03-21
• Last updated: 2020-09-09

Locations

1 site across 1 country: Belgium