Clinical trial · Interventional
Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
NCT06377371CI-TRIAL-00104272recruitingPhase 4ClinicalTrials.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)
The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.
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 |
|---|---|---|---|
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Imaging with [Cu64]DOTATATE | Diagnostic Test | — | UNRESOLVED |
| Radio-guided Surgery With Neoprobe Utilization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with MRI findings compatible with meningioma who have an indication for surgery
- description
- A diagnostic intervention in which patients will undergo intraoperative meningioma tracing using \[Cu64\]DOTATATE.
- interventionNames
- Diagnostic Test: Brain Imaging with [Cu64]DOTATATE
- Procedure: Radio-guided Surgery With Neoprobe Utilization
Primary outcomes (9)
- measure
- Preoperative [Cu64]DOTATATE PET SUV
- timeFrame
- At time of enrollment
- description
- preoperative lesion \[Cu64\]DOTATATE PET SUV
- measure
- 1st Post-operative [Cu64]DOTATATE PET SUV
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria, or diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery. Exclusion Criteria: * Pregnant or breastfeeding * Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed * Patients with hypersensitivity to somatostatin analogs * Patients with contraindications to conventional MRI * Patients with prior history of cranial radiation therapy * Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.