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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

Primary Purpose

Brain Tumor, Cervical Cancer

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FTX
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FTX

Arm Description

The radioactive tracer (FAZA)

Outcomes

Primary Outcome Measures

To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05047913
Brief Title
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Official Title
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
April 6, 2025 (Anticipated)
Study Completion Date
April 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-FTX
Arm Type
Experimental
Arm Description
The radioactive tracer (FAZA)
Intervention Type
Drug
Intervention Name(s)
18F-FTX
Intervention Description
Given By IV
Primary Outcome Measure Information:
Title
To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Chung
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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