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

• Status: Recruiting
• Trial end date: 2025-04-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

Criteria

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.