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

NCT02150408 | Completed

• 1 other identifier: 2013-27
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-Entero-Pancreatic Tumors (GEPs)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (1)

assesment by 68Ga-DOTATATE PET-CT

EXPERIMENTAL

Other: PET-CT

Interventions

PET-CT OTHER

assesment by 68Ga-DOTATATE PET-CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

Location

Study Officials

• David TAIEB, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: April 22, 2014
• Primary Completion: May 24, 2017
• Study Completion: April 5, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

FR (1)