Fluorescence Guided Resection of Brain Tumors

Completed · Phase 1

Conditions studied: Brain Tumors

In brief

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 tumor begins or ends. The surgeon usually can remove most of your tumor by looking at the MRI images that were taken of your 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 your chances of survival. It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.

Key facts

Study ID: NCT00870779
Run by: David W. Roberts
People needed: 105
Starts: 2007-05-01
Expected to finish: 2013-07-02
Last updated by the study team: 2019-06-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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