Brain Tumors
Conditions
Keywords
Fluorescence, Brain Tumors, Brain Metastases, Malignant Glioma, Brain Lesions
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 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.
Interventions
Sponsors
David W. Roberts
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology | Up to five years from the first surgery date | To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid W. Roberts, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed