ALA-induced PpIX Fluorescence During Brain Tumor Resection

Sponsor

David W. Roberts (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02191488

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

540

Enrollment

Location

Arm

120

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumors	Drug: 5-aminolevulinic acid	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection

Actual Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: 5-aminolevulinic acid 20mg/kg 3 hours prior to surgery	Drug: 5-aminolevulinic acid Other Names: 5-ALA

Arm

Intervention/Treatment

Experimental: Experimental: 5-aminolevulinic acid

20mg/kg 3 hours prior to surgery

Drug: 5-aminolevulinic acid

Other Names:

5-ALA

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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