Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

Description

This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.

Conditions

Brain Cancer

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Study Overview

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Study Details

Study overview

This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

Condition
Brain Cancer
Intervention / Treatment

-

Contacts and Locations

Lebanon

Sally B Mansur, Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
  • 2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
  • 3. Valid informed consent by subject or subject's LAR.
  • 4. No serious associated psychiatric illnesses.
  • 5. Age ≥ 21 years old.
  • 1. Pregnant women or women who are breast feeding.
  • 2. History of hypersensitivity to fluorescein.
  • 3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
  • 4. History of liver disease within the last 12 months.
  • 5. Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery.
  • 6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
  • 7. Inability to comply with the photosensitivity precautions associated with the study.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

David W. Roberts,

David W Roberts, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

2026-12