Study on Using Fluciclovine PET Scans for Planning Radiation Therapy in Patients with Newly Diagnosed Glioblastoma

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04840069

Provider View

This clinical trial is exploring whether adding a special PET scan using 18F-fluciclovine to the usual MRI and CT scans can improve radiation therapy planning for patients with newly diagnosed glioblastoma, a type of brain cancer. The study also aims to see if this approach helps patients live longer and tracks where the tumor might return.

Patient Parameters

Program Overview

The study aims to find out if using a PET scan with 18F-fluciclovine, along with the usual MRI and CT scans, can better identify areas for radiation therapy in patients with newly diagnosed glioblastoma. Researchers want to see if this method helps patients live longer and gather information on where the tumor might come back. They will also look at any side effects from using this new imaging method. 18F-Fluciclovine is a special substance that helps highlight cancer cells during a PET scan. While it's approved for detecting prostate cancer, it's still being tested for this purpose in glioblastoma.

Description

Glioblastoma is a common and aggressive brain cancer. Standard treatment includes surgery to remove as much of the tumor as possible, followed by radiation therapy and a chemotherapy drug called temozolomide. This approach has improved survival rates, but many patients still face a poor prognosis, with survival typically around 15-16 months.

This study is testing whether using a PET scan with 18F-fluciclovine can improve radiation therapy planning. The goal is to reduce the chances of the cancer returning in the same area. Researchers will compare this new method to the standard imaging techniques to see if it helps patients live longer and if it affects where the tumor might come back. They will also monitor any side effects from the different imaging methods.

The study builds on recent advances, such as the use of tumor-treating fields (TTF) and temozolomide, which have shown benefits in treating glioblastoma. However, despite these improvements, better treatment options are still needed to improve outcomes for patients with this challenging disease.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with a specific type of brain cancer called glioblastoma (WHO grade IV glioma).
  • Age 18 or older.
  • Good overall health with a performance score above 70%.
  • Recovered from surgery and on a stable or reducing dose of steroids.
  • Planning to start standard treatment with radiation and temozolomide within 6 weeks of surgery.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study.
  • Expected to live at least 3 more months.
  • Willing to sign a consent form specific to this study.

Exclusion Criteria

  • Previous treatment for glioma with certain drugs within 6 months before the imaging used for planning radiation therapy.
  • Recurrent or multiple malignant gliomas.
  • Cancer that has spread to other parts of the body.
  • Prior use of certain treatments directly in the tumor or cavity.
  • Previous radiation to the head or neck that overlaps with the current treatment area.
  • Planning to use targeted therapies during radiation therapy.
  • Participating in other clinical trials that could interfere with this study.
  • Unable to undergo MRI or PET scans due to medical reasons.
  • Pregnant or breastfeeding women.
  • Any other cancer within the last 3 years, except for certain early-stage skin cancers.

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