RECRUITING

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients with Glioma

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 trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.

Official Title

GA-68 PSMA-11 PET to Evaluate Malignant Glioma Recurrence - a Pilot Study

Quick Facts

Study Start:2024-07-26
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06444412

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. * Age ≥ 18 years.
  2. * History of World Health Organization (WHO) grade III or IV infiltrating glioma previously treated with first-line chemoradiotherapy.
  3. * MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.
  4. * Planned craniotomy for resection of suspected disease recurrence.
  5. * Willing to sign release of information for any radiation and/or follow-up records.
  6. * Ability to provide informed written consent.
  7. * Ability to provide tissue for mandatory correlative research component.
  1. * Previous treatment with antiangiogenic therapy (e.g. bevacizumab).
  2. * Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
  3. * Any of the following:
  4. * Pregnant women
  5. * Nursing women
  6. * Men or women of childbearing potential unwilling to employ adequate contraception

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Brian J. Burkett, MD, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Brian J. Burkett, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

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 Date2024-07-26
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • WHO Grade 3 Glioma
  • WHO Grade 4 Glioma