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

Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608203
Acronym
GEP-NOC
Enrollment
18
Registered
2015-11-18
Start date
2016-05-26
Completion date
2020-06-30
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Brief 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).

Interventions

DRUG[68Ga]-DOTANOC PET/CT

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frame
level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET6 months

Secondary

MeasureTime frame
Positive predictive values of DOTANOC PET and standard imaging1 year
negative predictive values of DOTANOC PET and standard imaging1 year
correlation between tumor type and DOTANOC PET results1 year
number of patients for whom PET allowed the detection of lesions not described by standard imaging6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026