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

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Brain Tumor

Cervical Cancer

Treatments

Drug: 18F-FTX

Study type

Interventional

Funder types

Other

Identifiers

NCT05047913

NCI-2021-10764 (Other Identifier)

2020-0285

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.