RECRUITING

Evaluation of the CONVIVO System

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

The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.

Official Title

Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection

Quick Facts

Study Start:2022-06-28
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05139277

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (age\>18)
  2. * Adults presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates
  3. * Adults able to provide informed consent.
  1. * Pregnancy
  2. * Children (age \<18 years)
  3. * Fluorescein sodium (FNa) allergy

Contacts and Locations

Study Contact

Linton T Evans, MD
CONTACT
603-650-5026
Linton.T.Evans@hitchcock.org

Principal Investigator

Linton T Evans, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Linton T Evans, 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 Date2022-06-28
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-06-28
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma
  • Glial Tumor
  • Brain Metastases
  • Meningioma
  • Schwannoma
  • Pituitary Tumor