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

April 5, 2023 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13005
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: assesment by 68Ga-DOTATATE PET-CT
Other: PET-CT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12-15 months
12-15 months

Other Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12-15 months
12-15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: David TAIEB, MD, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2014

Primary Completion (Actual)

May 24, 2017

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-27 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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