RECRUITING

Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma

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 the this study is to see if the use of a PET scan with 18F-fluciclovine (PET or Fluciclovine PET) in addition to the normal radiation planning imaging procedures (MRI and CT scan) will help determine the areas where the radiation therapy is to be delivered. It is also a goal of the study to determine if subjects live longer when treatment plans for radiation therapy are designed using a Fluciclovine PET scan, as well as MRI and CT scans. We will also collect information on if and where the tumor returns. Information on the side effects from the two different treatment planning imaging methods will also be collected. 18F-Fluciclovine is an FDA-approved radioactive diagnostic agent that is injected into the patient and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-Fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.

Official Title

A Phase II Randomized Clinical Trial of Radiotherapy Planning Using Conventional Imaging +/- Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma

Quick Facts

Study Start:2021-06-07
Study Completion:2024-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04840069

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. * Histological diagnosis of primary, newly diagnosed supratentorial, WHO grade IV glioma
  2. * Greater than 18 years of age
  3. * Karnofsky performance score greater than 70%
  4. * Recovered from surgery and on a stable or tapering dose of corticosteroids
  5. * Plan to undergo standard therapy with XRT 60Gy/30fx with TMZ followed by 6-12 cycles of maintenance TMZ within 6 weeks of surgery
  6. * If woman of child bearing potential, negative serum pregnancy test. Patients must agree to take adequate pregnancy preventions for the length of the study.
  7. * Life expectancy of at least 3 months
  8. * Written study specific consent
  1. * Previous treatment of glioma of any grade with bevacizumab or other molecular targeted therapies less than 6 months before MRI (and PET) used for radiotherapy planning
  2. * Recurrent of multifocal malignant glioma
  3. * Any sites of distant disease (for example drop metastases or leptomeningeal spread)
  4. * Prior use of Gliadel wafers or any other intratumal or intracavity treatment
  5. * Prior radiotherapy to the cranium, head and neck or other sites resulting in overlapping fields
  6. * Molecular targeted therapies planned during radiotherapy
  7. * Simultaneous participation in other interventional trials which could interfere with this trial or participation in a clinical trial within the last thirty days before patient's enrollment in current study.
  8. * Inability to undergo an MRI or PET (Claustrophobia, non-MRI compatible pacemaker, known allergy to MRI contrast agent or fluciclovine tracer)
  9. * Any pregnant or lactating patient
  10. * Any prior malignancy within 3 years excluding carcinoma in-situ or early staged,localized basal or squamous cell skin cancers

Contacts and Locations

Study Contact

Phase 0 Navigator
CONTACT
602-406-8605
research@ivybraintumorcenter.org

Study Locations (Sites)

St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States

Collaborators and Investigators

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

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 Date2021-06-07
Study Completion Date2024-03-30

Study Record Updates

Study Start Date2021-06-07
Study Completion Date2024-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Newly Diagnosed Glioblastoma