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

Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for 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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Procedure: 68Ga-DOTATOC PET-CT Imaging

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who is suspected of endocrine tumors

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of PET imaging	The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up.	Inclusion (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility	The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses	Inclusion (day 0)
Tolerance	Tolerance of the tracer will be assessed by the collection of possible side effects	Inclusion (day 0) and until end of follow up (day 28)
Impact on the therapeutic management	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.	End of follow up (day 28)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Philippe FERNANDEZ, Professor, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Endocrine Gland Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Edotreotide
• Other Study ID Numbers: CHUBX2012/28; 2013-003927-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No