Development of an innovative tracer imaging of neuro-endocrine tumors and preliminary clinical evaluatio

Active, not recruiting

• Conditions: neuroendocrine tumors; MedDRA version: 16.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2013-003927-12-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-21
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients over 18 years
- Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
- initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
- Search of the primary tumor, especially in the case of the inaugural discovery of metastases
- staging of a known recurrence
- Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
- Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
- Patient who have signed an informed consent
- Patient affiliated or beneficiary of regime of social security of a Member State of the European community

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Patient with another evolutive cancer disease and/or treated for less than 5 years
- Pregnant or lactating woman
- Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
- Patient unable to give their free and informed consent
- Persons placed under judicial protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: validate the radiosynthesis of 68Ga-DOTATOC on our site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.;Secondary Objective: Confirm the reproducibility of the synthesis of 68Ga-DOTATOC<br>Confirm the perfect tolerance of 68Ga-DOTATOC.<br>Estimate the clinical impact of the use of PET-CT with 68Ga-DOTATOC within the examinations of imaging by the rate of modification of the therapeutic attitude by the analysis of questionnaire;Primary end point(s): Diagnostic performance with 68Ga-DOTATOC PET-CT compared to standard examinations;Timepoint(s) of evaluation of this end point: Inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Impact on the therapeutic management of patients will be studied by the analysis of questionnaires with or without taking into account the results of the PET-CT with 68Ga-DOTATOC. Evaluate a potential change in the therapeutic attitude, induced by the results of 68Ga-DOTATOC PET-CT.;Timepoint(s) of evaluation of this end point: Inclusion