NCT02691923 Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
| NCT ID | NCT02691923 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | David W. Roberts |
| Condition | Brain Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2016-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
Eligibility Criteria
Inclusion Criteria: 1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme). 2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. 3. Valid informed consent by subject or subject's LAR. 4. No serious associated psychiatric illnesses. 5. Age ≥ 21 years old. Exclusion Criteria: 1. Pregnant women or women who are breast feeding. 2. History of hypersensitivity to fluorescein. 3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis. 4. History of liver disease within the last 12 months. 5. Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery. 6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery. 7. Inability to comply with the photosensitivity precautions associated with the study.
Contact & Investigator
Sally B Mansur, MS
✉ Sally.B.Mansur@Dartmouth.eduDavid W Roberts, MD
PRINCIPAL INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Frequently Asked Questions
Who can join the NCT02691923 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Brain Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02691923 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02691923 currently recruiting?
Yes, NCT02691923 is actively recruiting participants. Contact the research team at Sally.B.Mansur@Dartmouth.edu for enrollment information.
Where is the NCT02691923 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT02691923 clinical trial?
NCT02691923 is sponsored by David W. Roberts. The principal investigator is David W Roberts, MD at Dartmouth-Hitchcock Medical Center. The trial plans to enroll 30 participants.
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