NCT03576040: GAPET-NET

Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors

Completed Last updated 25 June 2025

What this trial tests

trial testing Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors in 120 participants. Completed in 6 July 2023.

Timeline

19 July 2018

Primary endpoint
6 July 2023

6 July 2023

Quick facts

Lead sponsor	University Hospital, Brest
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	19 July 2018
Primary completion	6 July 2023
Estimated completion	6 July 2023
Sites	1 location across France

Drugs / interventions tested

• Whole Body Dynamic 68Ga-DOTATOC PET/CT

Conditions studied

• Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →

Sponsor

University Hospital, Brest

Who can join

Adults 18 to 100, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.

However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.

Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.

Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.

However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.

The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective study of dynamic whole-body 68Ga-DOTATOC-PET/CT acquisition in patients with well-differentiated neuroendocrine tumors.
   Thuillier P, Bourhis D, Metges JP, Le Pennec R, et al · · 2021 · cited 6× · PMID 33649421 · DOI 10.1038/s41598-021-83965-9
2. Diagnostic performance of a whole-body dynamic 68GA-DOTATOC PET/CT acquisition to differentiate physiological uptake of pancreatic uncinate process from pancreatic neuroendocrine tumor.
   Thuillier P, Bourhis D, Karakatsanis N, Schick U, et al · · 2020 · cited 6× · PMID 32871968 · DOI 10.1097/md.0000000000020021
3. Population-based input function (PBIF) applied to dynamic whole-body 68Ga-DOTATOC-PET/CT acquisition.
   Thuillier P, Bourhis D, Pavoine M, Metges JP, et al · · 2022 · cited 5× · PMID 39390995 · DOI 10.3389/fnume.2022.941848