Clinical trial · Interventional
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study
A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection
NCT01248754CI-TRIAL-00024366completedPhase 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)
The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.
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 |
|---|---|---|---|
| Cancer (High-grace Glioma) | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical neuronavigation with 18F-DOPA PET imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DOPA PET imaging
- description
- Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.
- interventionNames
- Procedure: Surgical neuronavigation with 18F-DOPA PET imaging
Primary outcomes (1)
- measure
- The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.
- timeFrame
- Less than 72 hours postoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma * Karnofsky Performance status (KPS) ≥ 70 * Age ≥18 years * Subject is able to understand and consent to study * Glomerular filtration rate (GFR) ≥ 45 ml/minute Exclusion Criteria: * Indication for urgent craniotomy to relieve mass effect * Only stereotactic biopsy indicated because tumour is located in eloquent brain. * The enhancement on the T1 MRI sequence involves or abuts the basal ganglia * Previous intracranial malignancy or any invasive malignancy unless free of disease \> 5 years * Prior cranial irradiation * Contra-indications to systemic radiation exposure: pregnancy or breast feeding * Subject exceeds the weight limit of the PET scanner bed (204.5 kg) * Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease * Allergies or other contraindication to CT contrast or MRI contrast
References
Publications (0)
Data not yet available
No reference posted for this study.