Clinical trial · Interventional
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors
Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors
- 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)
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
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 |
|---|---|---|---|
| Patients With Gastroenteropancreatic Neuroendocrine Tumors | Digestive System Neuroendocrine Tumor | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68-Ga-DOTANOC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68-Ga-DOTANOC
- interventionNames
- Drug: 68-Ga-DOTANOC
Primary outcomes (1)
- measure
- Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
- timeFrame
- 12 months
- description
- Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
Secondary outcomes (1)
- measure
- Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * effective contraception or exclusion of pregnancy dosage of beta-HCG in women of childbearing age * Fortuitous discovery of suggestive tumors of TE-GEP with well documented conventional imaging (multiphase CT; MRI, US endoscopy) associated or not associated with clinical or biological signs of TE-GEP tumors (increase in tumor markers) OR * Histologically proven GEP-TE (WHO classification 2010 (26) well differentiated in the initial staging OR * Suspicion of recurrence or progression of well differentiated TE-GEP tumors on conventional imaging or laboratory tests (increase in tumor markers) OR * Clinical or biological syndrome strongly suggestive of digestive endocrine disease without identification of lesions with conventional imaging * Informed consent and patient's written * Affiliation to an insurance Exclusion Criteria: * Multiple endocrine neoplasia * TE GEP tumor not differentiated * Pregnancy and lactation * Persons protected by law * Restlessness, inability to lie still hold at least 1 hour; Claustrophobia * Poor compliance predictable or inability to undergo medical test for geographical, social or psychological * Treatment with radiotherapy, chemotherapy or other antitumor treatment within 6 weeks of previous morphological and scintigraphic examinations. In case of treatment with somatostatin analogues delayed, scans will be performed 4 weeks after the last injection. However, a shorter period may be observed to avoid to do again the initial assessment exams. * malignancy except basal cell cancers and cancer in situ of the cervix * Contraindication of injection of a contrast agent necessary for the production of multiphase scanner. * Patients who had a CT scan without injection of contrast material can not participate in the study
References
Publications (0)
Data not yet available