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:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT04019002
Eligibility Criteria:
Inclusion Criteria:
* Cohort 1: Histologically proven newly diagnosed glioblastoma multiforme (GBM) who will undergo standard of treatment with radiation therapy (RT) and temozolomide (TMZ).
* Cohort 2: Histologically proven recurrent suspected GBM who will receive surgical resection for the recurrence.
* Cohort 3: Histologically proven recurrent suspected GBM who will undergo standard treatment for the recurrence.
* Patients must be \>/= 18 years old and with a life expectancy \> 16 weeks.
* Patients must have a Karnofsky performance status of ≥ 70.
* Patients must have adequate renal function: creatinine \< 1.5 mg/dL before imaging. These tests must be performed within 60 days prior to Hyperpolarized Imaging scan.
* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.
* Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
* Patients must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
* This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
* Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
* Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
* Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.
Exclusion Criteria:
* Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04019002
Study Brief:
Protocol Section:
NCT04019002