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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

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Procedure: 68Ga-DOTATOC PET-CT Imaging

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient who is suspected of endocrine tumors
According to symptomatology, biology or imaging or pathological context
Procedure: 68Ga-DOTATOC PET-CT Imaging



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reproducibility [ Time Frame: Inclusion (day 0) ]
    The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who is suspected of endocrine tumors
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

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 ClinicalTrials.gov identifier (NCT number): NCT02134639


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Philippe FERNANDEZ, Professor University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02134639     History of Changes
Other Study ID Numbers: CHUBX2012/28
2013-003927-12 ( EudraCT Number )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Endocrine Gland Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Site
Endocrine System Diseases
Edotreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action