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PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation (GALTEP)

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ClinicalTrials.gov Identifier: NCT02134639
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date February 4, 2014
First Posted Date May 9, 2014
Last Update Posted Date August 4, 2017
Actual Study Start Date September 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2014)
Evaluation of PET imaging [ Time Frame: Inclusion (day 0) ]
The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2014)
  • Reproducibility [ Time Frame: Inclusion (day 0) ]
    The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses
  • Tolerance [ Time Frame: Inclusion (day 0) and until end of follow up (day 28) ]
    Tolerance of the tracer will be assessed by the collection of possible side effects
  • Impact on the therapeutic management [ Time Frame: End of follow up (day 28) ]
    The 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Official Title Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Brief Summary Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient who is suspected of endocrine tumors
Condition Neuroendocrine Tumors
Intervention Procedure: 68Ga-DOTATOC PET-CT Imaging
Study Groups/Cohorts Patient who is suspected of endocrine tumors
According to symptomatology, biology or imaging or pathological context
Intervention: Procedure: 68Ga-DOTATOC PET-CT Imaging
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 Completed
Actual Enrollment
 (submitted: May 7, 2014)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02134639
Other Study ID Numbers CHUBX2012/28
2013-003927-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Philippe FERNANDEZ, Professor University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date August 2017