Recruiting
Phase 2

Fluciclovine PET

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT04840069

Conditions

Newly Diagnosed Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluciclovine PET guided Radiotherapy

Study Details

Brief summary:

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.

Conditions

Newly Diagnosed Glioblastoma

Study ID

NCT04840069

Start date

Jun 7, 2021

Status verified date

Jan, 2023

Completion date

Mar 30, 2024

Anticipated

Primary completion date

Mar 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological diagnosis of primary, newly diagnosed supratentorial, WHO grade IV glioma
  • Greater than 18 years of age
  • Karnofsky performance score greater than 70%
  • Recovered from surgery and on a stable or tapering dose of corticosteroids
  • Plan to undergo standard therapy with XRT 60Gy/30fx with TMZ followed by 6-12 cycles of maintenance TMZ within 6 weeks of surgery
  • If woman of child bearing potential, negative serum pregnancy test. Patients must agree to take adequate pregnancy preventions for the length of the study.
  • Life expectancy of at least 3 months
  • Written study specific consent

Exclusion Criteria:

  • 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
  • Recurrent of multifocal malignant glioma
  • Any sites of distant disease (for example drop metastases or leptomeningeal spread)
  • Prior use of Gliadel wafers or any other intratumal or intracavity treatment
  • Prior radiotherapy to the cranium, head and neck or other sites resulting in overlapping fields
  • Molecular targeted therapies planned during radiotherapy
  • 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.
  • Inability to undergo an MRI or PET (Claustrophobia, non-MRI compatible pacemaker, known allergy to MRI contrast agent or fluciclovine tracer)
  • Any pregnant or lactating patient
  • Any prior malignancy within 3 years excluding carcinoma in-situ or early staged,localized basal or squamous cell skin cancers

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: MRI-guided radiotherapy

Patients will undergo standard of care MRI-guided radiotherapy.

experimental: MRI + Fluciclovine PET-guided radiotherapy

Patients will undergo MRI + Fluciclovine PET-guided radiotherapy

Interventions

Fluciclovine PET guided Radiotherapy

PET+MRI Based There is no GTV_5400. The GTV_6000 will be defined as the surgical cavity inclusive of any remaining tumor enhancement and the hypermetabolic volume. CTV_5400 will include the GTV_6000 plus a margin of 1.0 cm which may be reduced around natural barriers to tumor growth such as the skull, ventricles, falx, etc. CTV_5400 must also include the entirety of the GTV_6000. There is no CTV_6000. PTV_5400 is the CTV_5400 plus a geometric 3 mm expansion in all dimensions; PTV_6000 is GTV_6000 plus a geometric 3 mm expansion in all dimensions. PTV may extend beyond bony margins and the skin surface. The PTV_5400 must contain the PTV_6000. In the setting of multi-focal disease, the primary target volumes will be defined as above, but for satellite lesions, the GTV_6000 will be defined as any tumor enhancement and hypermetabolic volume. There will be no CTV_6000. PTV_6000 will be defined as GTV_6000 plus a geometric 3 mm expansion in all dimensions.

Primary outcome measure

  • Patterns of Failure [ Time Frame: 36 months ]
  • Defining Tumor Volume [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Phase 0 Navigator

602-406-8605research@ivybraintumorcenter.org

Locations

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Phase 0 Navigator

602-406-8605research@ivybraintumorcenter.org

Principal Investigator:

Igor Barani, MD

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Jan 13, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2023-01-13.