Status:
COMPLETED
Fluorescence Guided Resection of Brain Tumors
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 your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the ...
Detailed Description
The first phase of study (Stage I) will use FI coregistered with pMR, iUS and iSV images to test the overall hypothesis that there is a high degree of spatial correlation between local tissue FI signa...
Eligibility Criteria
Inclusion
- Preoperative diagnosis of either presumed low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme) or meningioma, pituitary adenoma or metastasis.
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Patient able to provide written informed consent.
- 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,
- AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the previous 2 months
- Plasma creatinine in excess of 180 mol/L.
- Inability to comply with the photosensitivity precautions associated with the study
- Patients with an existing DSM-IV Axis 1diagnosis
- Inability to give informed consent
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00870779
Start Date
May 1 2007
End Date
July 2 2013
Last Update
June 14 2019
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756