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

Neuroendocrine Tumors Clinical Trial

— GALTEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134639
• Other study ID #: CHUBX2012/28
• Secondary ID: 2013-003927-12
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: August 3, 2017
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Endocrine Gland Neoplasms
• Neuroendocrine Tumors

Intervention

Procedure:
• 68Ga-DOTATOC PET-CT Imaging

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproducibility	The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses	Inclusion (day 0)
Secondary	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)
Secondary	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)