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Trial Title:
ALA-induced PpIX Fluorescence During Brain Tumor Resection
NCT ID:
NCT02191488
Condition:
Brain Tumors
Conditions: Official terms:
Brain Neoplasms
Aminolevulinic Acid
Conditions: Keywords:
Fluorescence
Brain Tumors
Brain Metastases
Malignant Glioma
Brain Lesions
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
5-aminolevulinic acid
Arm group label:
Experimental: 5-aminolevulinic acid
Other name:
5-ALA
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 exactly where the tumor begins or ends. The surgeon usually can remove
most of the patient's tumor by looking at the MRI images that were taken of the patient's
brain before surgery. However, the surgeon does not have any good way to tell if the
entire tumor has been removed or not. Removing the entire tumor is very important because
leaving tumor behind may allow it to grow back which could decrease the chances of
survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dartmouth-Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Start date:
July 2014
Completion date:
July 31, 2026
Lead sponsor:
Agency:
David W. Roberts
Agency class:
Other
Collaborator:
Agency:
National Institute of Neurological Disorders and Stroke (NINDS)
Agency class:
NIH
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02191488
