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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02608203
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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).

Condition or disease Intervention/treatment Phase
Gastroenteropancreatic Neuroendocrine Tumors Drug: [68Ga]-DOTANOC PET/CT Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: patients with gastroenteropancreatic neuroendocrine tumors Drug: [68Ga]-DOTANOC PET/CT

Primary Outcome Measures :
  1. level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Positive predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
  2. negative predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
  3. correlation between tumor type and DOTANOC PET results [ Time Frame: 1 year ]
  4. number of patients for whom PET allowed the detection of lesions not described by standard imaging [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02608203

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Contact: David TAIEB, MD

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Marseille, France
Contact: David TAIEB, MD   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: Urielle Desalbres AP-HM
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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT02608203    
Other Study ID Numbers: 2014-46
RCAPHM14_0345 ( Registry Identifier: AP-HM )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases