RECRUITING

MRI in High-Grade Glioma Patients Undergoing Chemoradiation

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 purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.

Official Title

A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation

Quick Facts

Study Start:2022-09-02
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05212272

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. * Pathologically confirmed diagnosis of high grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme \[GBM\]).
  2. * ≥18 years of age.
  3. * ECOG performance status of 0 to 3
  4. * Anticipated to receive 6 weeks of chemoradiation
  1. * Does not speak or read English
  2. * Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.
  3. * Unable to give informed consent
  4. * Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor
  5. * Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan
  6. * Currently taking cognition-enhancing medications including:
  7. * Donepezil
  8. * Memantine
  9. * Armodafinil
  10. * Methylphenidate
  11. * Pregnant or nursing mothers.
  12. * Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
336-716-0892
camjohns@wakehealth.edu
Study Nurse
CONTACT
336-713-3539
arcarrol@wakehealth.edu

Principal Investigator

Christina Cramer, MD
PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Christina Cramer, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer 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 Date2022-09-02
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-09-02
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • High Grade Glioma