Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04840069
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04840069
Study Brief:
Protocol Section:
NCT04840069