Clinical trial · Interventional
PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATOC PET-CT Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient who is suspected of endocrine tumors
- description
- According to symptomatology, biology or imaging or pathological context
- interventionNames
- Procedure: 68Ga-DOTATOC PET-CT Imaging
Primary outcomes (1)
- measure
- Evaluation of PET imaging
- timeFrame
- Inclusion (day 0)
- description
- 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 (3)
- measure
- Reproducibility
- timeFrame
- Inclusion (day 0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMorgat 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 26819103