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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

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