Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors

Not Applicable

Completed

• Conditions: Gastro-Entero-Pancreatic Tumors (GEPs)
• Interventions: Other: PET-CT

• Registration Number: NCT02150408
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.

Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.

The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-22
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Primary Completion: 2017-05-24
• Status Verified: 2023-04
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• • Age ≥ 18,

  • Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach
  • Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT).

Exclusion Criteria

• Pregnant or breast-feeding woman
• Other cancer disease
• GEP with grade 3 tumours
• Non GEP TNE (paragangliome, medullar thyroid cancer)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
assesment by 68Ga-DOTATATE PET-CT	PET-CT	-

Primary Outcome Measures

Name	Time	Method
interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging	12-15 months

Secondary Outcome Measures

Name	Time	Method
therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT	12-15 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France