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ALA-induced PpIX Fluorescence During Brain Tumor Resection
Conditions
Brain Tumors
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Fluorescence, Brain Tumors, Brain Metastases, Malignant Glioma, Brain Lesions
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 5-aminolevulinic acid
Type: Drug
Overall Status
Recruiting
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 patients tumor by looking at the MRI images that were taken of the patients 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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
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 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.
- Inability to give informed consent.
- Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
- 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 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.
- Inability to give informed consent.
- Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
Location
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Margaret A Notestine, CCRC - 603-650-4607 - Margaret.A.Notestine@hitchcock.org
Start Date
July 2014
Sponsors
Dartmouth-Hitchcock Medical Center
Source
Dartmouth-Hitchcock Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page