Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR

Study Overview
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Brief Summary
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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

Official Title
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Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR

Conditions
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Brain Tumor, Cervical Cancer

Intervention / Treatment
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* Drug: 18F-FTX


Participation Criteria
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Eligibility Criteria
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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 medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance. Cervical Cohort Prior nephrectomy or planned nephrectomy. 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 and MRI. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FTX<br>The radioactive tracer (FAZA) | Drug: 18F-FTX<br>* Given By IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake. |  | through study completion, an average of 1 year |