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Completed

NCT Number: NCT02134639

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

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-DOTATOC PET-CT Imaging

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation

Acronym: GALTEP

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 9, 2014
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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