NCT02134639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 9, 2026

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

February 4, 2014

Last Update Submit

June 5, 2026

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reproducibility

    Inclusion (day 0)

  • Tolerance

    Inclusion (day 0) and until end of follow up (day 28)

  • Impact on the therapeutic management

    End of follow up (day 28)

Study Arms (1)

Patient who is suspected of endocrine tumors

EXPERIMENTAL

According to symptomatology, biology or imaging or pathological context

Procedure: 68Ga-DOTATOC PET-CT Imaging

Interventions

68Ga-DOTATOC PET-CT ImagingPROCEDURE
Patient who is suspected of endocrine tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

  • Morgat C, Velayoudom-Cephise FL, Schwartz P, Guyot M, Gaye D, Vimont D, Schulz J, Mazere J, Nunes ML, Smith D, Hindie E, Fernandez P, Tabarin A. Evaluation of (68)Ga-DOTA-TOC PET/CT for the detection of duodenopancreatic neuroendocrine tumors in patients with MEN1. Eur J Nucl Med Mol Imaging. 2016 Jul;43(7):1258-66. doi: 10.1007/s00259-016-3319-3. Epub 2016 Jan 28.

    PMID: 26819103RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Philippe FERNANDEZ, Professor

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

May 9, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

June 9, 2026

Record last verified: 2017-08

Locations

FR(1)