Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma a… (NCT05047913) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
United States20 participantsStarted 2021-09-20
Plain-language summary
Primary Objectives To investigate the relationship between dynamic MRI, brain tumor perfusion (DSC) and permeability (DCE), and dynamic 18F-FAZA PET uptake.
Secondary Objectives To investigate the relationship between tumors with greater hypoxia defined by qBOLD and 18F-FAZA PET and pathological features including proportionate necrosis, Ki-67 and IDH mutation status
To investigate the correlation between the hypoxic tumor region delineated using 18F-FAZA PET and qBOLD
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Glioma Cohort
* Adult (\> 18 years old) patients with newly diagnosed or recurrent high grade glioma with newly confirmed pathology (within 1 month)
* Able to provide informed consent
* No contraindications to MRI with gadolinium contrast or 18F-FAZA PET
Cervical Cohort
* Adult (\>18 years old) female with newly diagnosed cervical cancer
* Able to provide informed consent
* Receiving surgery, radiotherapy or chemotherapy
* No contraindication to MRI with gadolinium contrast or 18F-FAZA PET
Exclusion Criteria:
Glioma Cohort
* Prior nephrectomy or planned nephrectomy.
* Prior brain radiation within 30 days.
* Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
* Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
* Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
* Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI.
* Any additional…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using a radioactive tracer called 18F-FAZA alongside MRI scans to study how oxygen, blood supply, and metabolism behave in high-grade glioma or cervical cancer tumors — can you explain what that would actually involve for me in terms of procedures, scan time, and any radiation exposure I should be aware of?
2Since this is an early Phase 1 study focused mainly on measuring and correlating imaging results rather than testing a treatment, would participating in it change or delay any active treatment I might otherwise be starting right now?
3The trial is listed as active but no longer recruiting new patients — does that mean there's any realistic chance I could still be considered, or should I focus my energy on other options?
4Because this study is primarily gathering data about tumor biology through imaging rather than offering a new therapy, what would you or the research team actually learn about my specific tumor, and would any of that information be shared with me or used to guide my care?
5Given that this involves both an 18F-FAZA PET scan and a multiparametric MRI in the same session, how physically demanding is that combination of scans, and are there any risks I should discuss with you before deciding whether this is worth pursuing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
Timeframe: through study completion, an average of 1 year