Clinical trial · Interventional
Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms
NCT05709171CI-TRIAL-00071614unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GEP-NET | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma Metastatic | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| 64Cu-Dotatate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Each patient will undergo one standard of care 18FDG PET/CT and one 64Cu-DOTATATE PET/CT within 4 weeks.
- interventionNames
- Drug: 18F-FDG
- Drug: 64Cu-Dotatate
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 12 months after last-patients-last-visit
- description
- Time to disease progression from PET/CT scans. Disease progression is defined as a composite measure (whichever occurs first) of RECIST-1.1 defined radiological progression, commencement of another systemic therapy and/or surgery/embolization/ablation related to worsening to the patient's disease status after the index scan, progression evaluated by a multidisciplinary tumor board, and death related to the patient's NEN disease. In case of uncertainty if progression has occurred, the patient's disease status will be evaluated by a multidisciplinary tumor board.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically verified gastro-entero-pancreatic neuroendocrine neoplasm (GEP-NEN) or patients with unknown primary tumor with metastases with verified NEN positive histopathological examination suggesting GEP origin * World Health Organization (WHO) Performance status 0-2 * Must be able to read and understand the patient information in Danish and to give informed consent Exclusion Criteria: * Pregnancy * Breast-feeding * Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg) * Uncontrolled diabetes * Uncontrolled infection * Exacerbation in autoimmune diseases * Other active cancer disease * Conditions or diseases (e.g. uncontrolled Parkinson's disease) making the patient unable to lie still in the scanner * Severe claustrophobia * Localized neuroendocrine neoplasms of the appendix, the rectum measuring \< 1 cm, and ECL-omas of the stomach * History of allergic reaction attributable to compounds of similar chemical or biologic com-position to 18FDG or 64Cu-DOTATATE
References
Publications (0)
Data not yet available
No reference posted for this study.