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CompletedNCT02608203GEP-NOCUpdated Oct 14, 2022

[68 Ga]-DOTANOC PET/CT in GEP-NETs

A Phase 2/3 interventional study of [68Ga]-DOTANOC PET/CT in Gastroenteropancreatic Neuroendocrine Tumors, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-14.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 2/3, Interventional, and Diagnostic

Phase
Phase 2/3
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs.

During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.

In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa.

Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.

[68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation.

It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients.

The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).

110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).

02

Conditions studied

  • Gastroenteropancreatic Neuroendocrine Tumors
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age> 18 years, with affiliation to the Social Security.
  2. Written consent of the patient.
  3. Patients with any of the following 5 situations:

    • GEPs without metastasis.
    • GEPs with unilateral liver metastases candidates to unilateral hepatectomy.
    • GEPs with unknown primary tumor.
    • GEPS with livers metastases candidates to liver transplantation.
    • Metastatic GEPs with grade 1 or 2 tumour and negative SRS.
  4. Reference imaging within the last 3 months : multiphasic total body CT scan, liver MRI and SRS (SPECT/CT).

Exclusion criteria

Exclusion Criteria:

  1. minor subject.
  2. Pregnant or breast-feeding.
  3. Absence of therapeutic alternatives in metastatic GEP.
  4. Undifferentiated GEP and/or metastatic GEPs with grade 3 tumours.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    patients with gastroenteropancreatic neuroendocrine tumors

    Drug: [68Ga]-DOTANOC PET/CT

Interventions

06

What researchers measure

Primary outcomes

  1. level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET

    Time frame: 6 months

Secondary outcomes

  1. Positive predictive values of DOTANOC PET and standard imaging

    Time frame: 1 year

  2. negative predictive values of DOTANOC PET and standard imaging

    Time frame: 1 year

  3. correlation between tumor type and DOTANOC PET results

    Time frame: 1 year

  4. number of patients for whom PET allowed the detection of lesions not described by standard imaging

    Time frame: 6 months

07

Study locations

1 site
  • AP-HM
    Marseille, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02608203
Responsible party
Sponsor
First posted
Nov 18, 2015
Start date
May 26, 2016
Primary completion
Jun 24, 2019
Completion
Jun 30, 2020
Last update
Oct 14, 2022

Study contacts

Urielle Desalbres
study director · AP-HM
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Gallium-68

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