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[68 Ga]-DOTANOC PET/CT in GEP-NETs (GEP-NOC)

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ClinicalTrials.gov Identifier: NCT02608203
Recruitment Status : Not yet recruiting
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Positive predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
  • negative predictive values of DOTANOC PET and standard imaging [ Time Frame: 1 year ]
  • correlation between tumor type and DOTANOC PET results [ Time Frame: 1 year ]
  • number of patients for whom PET allowed the detection of lesions not described by standard imaging [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [68 Ga]-DOTANOC PET/CT in GEP-NETs
Official Title  ICMJE Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastroenteropancreatic Neuroendocrine Tumors
Intervention  ICMJE Drug: [68Ga]-DOTANOC PET/CT
Study Arms  ICMJE Experimental: patients with gastroenteropancreatic neuroendocrine tumors
Intervention: Drug: [68Ga]-DOTANOC PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David TAIEB, MD david.taieb@ap-hm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608203
Other Study ID Numbers  ICMJE 2014-46
RCAPHM14_0345 ( Registry Identifier: AP-HM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urielle Desalbres AP-HM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP