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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2027-02-02

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

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Detailed Description

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Conditions

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Brain Tumor Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FTX

The radioactive tracer (FAZA)

Group Type EXPERIMENTAL

18F-FTX

Intervention Type DRUG

Given By IV

Interventions

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18F-FTX

Given By IV

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No