ALA-induced PpIX Fluorescence During Brain Tumor Resection

Brain Tumors Clinical Trial

Official title:

Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02191488
• Other study ID #: DMS 13066
• Secondary ID: R01NS052274-01A2
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: July 2026

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

Drug:
• 5-aminolevulinic acid

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
David W. Roberts	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology	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	Up to five years from the first surgery date