RECRUITING

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

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Conditions

Brain CancerHigh Grade GliomaLow Grade GliomaBrain Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-03
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02691923

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
  2. 2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
  3. 3. Valid informed consent by subject or subject's LAR.
  4. 4. No serious associated psychiatric illnesses.
  5. 5. Age ≥ 21 years old.
  1. 1. Pregnant women or women who are breast feeding.
  2. 2. History of hypersensitivity to fluorescein.
  3. 3. History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
  4. 4. History of liver disease within the last 12 months.
  5. 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. 6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
  7. 7. Inability to comply with the photosensitivity precautions associated with the study.

Contacts and Locations

Study Contact

Sally B Mansur, MS
CONTACT
Sally.B.Mansur@Dartmouth.edu
Keith D Paulsen, PhD
CONTACT
Keith.D.Paulsen@Dartmouth.edu

Principal Investigator

David W Roberts, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Sally B Mansur
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: David W. Roberts

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-03
Study Completion Date2026-12

Study Record Updates

Study Start Date2016-03
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • High Grade Glioma
  • Low Grade Glioma
  • Brain Tumor

Additional Relevant MeSH Terms

  • Brain Cancer