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Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma

NCT04840069 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-13

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Barrow Neurological Foundation

    collaborator OTHER

  • Arizona Biomedical Research Commission (ABRC)

    collaborator OTHER

  • Blue Earth Diagnostics

    collaborator INDUSTRY

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840069 on ClinicalTrials.gov