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ALA-induced PpIX Fluorescence During Brain Tumor Resection

Primary Purpose

Brain Tumors

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
5-aminolevulinic acid
Sponsored by
David W. Roberts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumors focused on measuring Fluorescence, Brain Tumors, Brain Metastases, Malignant Glioma, Brain Lesions

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: 5-aminolevulinic acid

Arm Description

20mg/kg 3 hours prior to surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 9, 2014
Last Updated
May 16, 2023
Sponsor
David W. Roberts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02191488
Brief Title
ALA-induced PpIX Fluorescence During Brain Tumor Resection
Official Title
Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2014 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David W. Roberts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
Fluorescence, Brain Tumors, Brain Metastases, Malignant Glioma, Brain Lesions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 5-aminolevulinic acid
Arm Type
Experimental
Arm Description
20mg/kg 3 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
5-aminolevulinic acid
Other Intervention Name(s)
5-ALA
Primary Outcome Measure Information:
Title
Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
Description
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
Time Frame
Up to five years from the first surgery date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Roberts, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28777025
Citation
Roberts DW, Olson JD, Evans LT, Kolste KK, Kanick SC, Fan X, Bravo JJ, Wilson BC, Leblond F, Marois M, Paulsen KD. Red-light excitation of protoporphyrin IX fluorescence for subsurface tumor detection. J Neurosurg. 2018 Jun;128(6):1690-1697. doi: 10.3171/2017.1.JNS162061. Epub 2017 Aug 4.
Results Reference
derived

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ALA-induced PpIX Fluorescence During Brain Tumor Resection

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