RECRUITING

Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma

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Conditions

High Grade Glioma

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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 feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-(\[2-\[F-18\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\[F-18\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.

Official Title

Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma

Quick Facts

Study Start:2024-03-07
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05632562

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:10 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required.
  2. 2. 10 years of age or older at the time of enrollment
  3. 3. Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed.
  4. 4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO.
  5. 5. ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.
  6. 6. Life expectancy greater than 12 weeks.
  1. 1. Recurrent glioma
  2. 2. Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.
  3. 3. Pregnancy or breast feeding
  4. 4. Inability to complete PET/MRI scans.
  5. 5. Significant renal dysfunction (estimated GFR \< 30 mL/min)
  6. 6. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
  7. 7. Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.

Contacts and Locations

Study Contact

Sebastian M Eady, BS
CONTACT
205-996-2636
smeady@uabmc.edu
Quenteeria S Mooney, BS
CONTACT
205-934-3747
qmooney@uabmc.edu

Principal Investigator

Jonathan McConathy, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

UAB
Birmingham, Alabama, 35249
United States
UAB
Birmingham, Alabama, 35249
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jonathan McConathy, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2024-03-07
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • High Grade Glioma