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CompletedNCT02150408DOTATATENETUpdated Apr 6, 2023

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

An interventional study of PET-CT in Gastro-Entero-Pancreatic Tumors (GEPs), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastro-Entero-Pancreatic Tumors (GEPs)
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 35 is below the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

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

Study arms

  • Experimental
    assesment by 68Ga-DOTATATE PET-CT

    Other: PET-CT

Interventions

  • OtherPET-CT
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What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 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

    Time frame: 12-15 months

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Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13005, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02150408
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
May 29, 2014
Start date
Apr 22, 2014
Primary completion
May 24, 2017
Completion
Apr 5, 2023
Last update
Apr 6, 2023

Study contacts

David TAIEB, MD
principal investigator · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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