Dynamic FAZA PET and Multiparametric MR Imaging for Brain Tumor

Overseen By Caroline Chung

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How does the treatment using Dynamic FAZA PET and Multiparametric MR Imaging for brain tumors differ from other treatments?

This treatment is unique because it combines PET and MR imaging to provide a detailed view of brain tumors, allowing doctors to see both the structure and function of the tumor. It uses a special tracer, (18)F-fluoroazomycin arabinoside ((18)F-FAZA), to detect low-oxygen areas in the tumor, which can help in identifying the most aggressive parts of the tumor for better treatment planning. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment 18F-FTX for brain tumors?

Research shows that similar imaging techniques using 18F-FET, a related compound, are valuable in diagnosing and monitoring brain tumors like gliomas. These techniques help distinguish between tumor growth and treatment effects, suggesting that 18F-FTX might also be effective in providing important information about brain tumors. ^{1 6 7 8 9}

Who Is on the Research Team?

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high grade glioma (brain tumor) or newly diagnosed cervical cancer. Participants must be receiving surgery, radiotherapy, or chemotherapy and have no issues with MRI or PET scans using specific contrasts. They should be able to give informed consent.

Inclusion Criteria

I am an adult woman with new cervical cancer, getting treatment, and can have MRI or PET scans.

I am an adult with a new or returning high-grade brain tumor and can undergo MRI and PET scans.

Exclusion Criteria

Glioma Cohort: Patients with prior nephrectomy or planned nephrectomy, prior brain radiation within 30 days, pregnant or lactating women, subjects with contraindications to the use of 18F-FAZA, patients with a body weight of 400 pounds or more, or BMI precluding entry into the PET-MRI scanner, and those with any additional medical condition, serious concurrent illness, or other extenuating circumstance that may significantly interfere with study compliance

I do not have conditions that prevent PET-MRI scans or weigh over 400 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Assessment

Participants undergo dynamic MRI, brain tumor perfusion (DSC), permeability (DCE), and dynamic 18F-FAZA PET imaging to evaluate tumor oxygenation, metabolism, and blood supply

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FTX

Trial Overview The study is testing the use of dynamic FAZA PET scans and multiparametric MR imaging to evaluate oxygen levels, metabolism, and blood supply in brain tumors and cervical cancers. It aims to understand how these factors relate to each other.

How Is the Trial Designed?

Group I: 18F-FTX Experimental Treatment 1 Intervention

The radioactive tracer (FAZA)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The study involved 47 glioma patients and 63 lesions, demonstrating that combined 18F-fluorethyltyrosine (FET)-PET/MRI is effective in distinguishing between tumor recurrence and treatment-related changes, with a high area under the curve (AUC) of 0.89 for multiparametric analysis.

Static PET showed the highest sensitivity (80%) and specificity (85%) for identifying recurrence, while the multiparametric approach improved diagnostic accuracy, particularly when high specificity was required.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of glioma recurrence using multiparametric dynamic 18F-fluoroethyl-tyrosine PET-MRI. Pyka, T., Hiob, D., Preibisch, C., et al.[2019]

The combination of MR and PET imaging techniques, particularly using amino acid tracers like (18)F-fluoroethyltyrosine, enhances the ability to accurately identify and delineate aggressive tumor areas in glioblastoma multiforme (GBM), which is crucial for effective treatment planning.

Simultaneous PET-MR imaging not only improves the quantification of PET signals but also reduces overall imaging time, making it more suitable for patients with GBM who are often in critical condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PET-MR in patients with glioblastoma multiforme]. Ertl-Wagner, B., Ingrisch, M., Niyazi, M., et al.[2021]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of 18F-FET-PET-MRI in Neuro-Oncology: The Best of Both Worlds-A Narrative Review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Larger 18F-fluoroboronotyrosine (FBY) active volume beyond MRI contrast enhancement in diffuse gliomas than in circumscribed brain tumors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

18F-FDOPA PET and MRI characteristics correlate with degree of malignancy and predict survival in treatment-na&#239;ve gliomas: a cross-sectional study. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Diagnosis of glioma recurrence using multiparametric dynamic 18F-fluoroethyl-tyrosine PET-MRI. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of [18F]Fluoroethyltyrosine PET and Sodium MRI in Cerebral Gliomas: a Pilot Study. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

PET/MRI: Multiparametric imaging of brain tumors. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

18F-fluoroethylcholine (18F-Cho) PET/MRI functional parameters in pediatric astrocytic brain tumors. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[PET-MR in patients with glioblastoma multiforme]. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Intratumoral heterogeneity of 18F-FLT uptake predicts proliferation and survival in patients with newly diagnosed gliomas. [2017]