Status:
ACTIVE_NOT_RECRUITING
ALA-induced PpIX Fluorescence During Brain Tumor Resection
Lead Sponsor:
David W. Roberts
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Tumors
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exac...
Eligibility Criteria
Inclusion
- Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Patient or LAR able to provide written informed consent.
- No serious associated psychiatric illnesses.
- Age \> 21 years old.
Exclusion
- Pregnant women or women who are breast feeding
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
- History of liver disease within the last 12 months.
- Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
- Inability to comply with the photosensitivity precautions associated with the study.
- Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT02191488
Start Date
July 1 2014
End Date
December 31 2026
Last Update
September 15 2025
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756