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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a new imaging tracer, 18F-FTX, can visualize brain and cervical tumors. The goal is to determine how this tracer interacts with MRI images to better understand tumor oxygen levels and other key features. It targets adults with newly diagnosed or recurrent high-grade gliomas (a type of brain tumor) or cervical cancer who are set to receive treatments like surgery or chemotherapy. Participants must be comfortable undergoing both MRI and PET scans. As an Early Phase 1 trial, this research focuses on understanding how the tracer works in people, offering participants the chance to be among the first to benefit from this innovative approach.

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.

What prior data suggests that this imaging technique is safe for brain tumor patients?

Research has shown that a 370-MBq injection of 18F-FAZA is safe for use in medical settings. This dosage is similar to other commonly used PET scan agents. Studies have found that people tolerate the radiation from 18F-FAZA well. No reports have linked serious side effects to this tracer, which aids doctors in visualizing brain tumors. Current evidence suggests that the treatment is generally safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-FTX because it offers a unique approach to imaging brain tumors. Unlike standard imaging techniques, which often rely on structural changes, 18F-FTX uses a radioactive tracer called FAZA to highlight areas of low oxygen levels in tumors. This method helps to identify aggressive tumor regions that might not be visible with other imaging methods. By providing more detailed and functional insights into the tumor environment, 18F-FTX could significantly enhance the precision of diagnosis and treatment planning for brain tumors.

What evidence suggests that this trial's treatments could be effective for brain tumors?

Research has shown that 18F-FAZA PET imaging, which participants in this trial will receive, can help identify low oxygen levels in brain tumors, aiding in their understanding and treatment. In a study with glioblastoma patients, this imaging method provided high contrast between the tumor and blood, clearly highlighting areas with low oxygen. This is crucial because tumors with low oxygen often respond differently to treatments. Additionally, combining 18F-FAZA PET with MRI may improve the accuracy of brain tumor diagnosis by offering more detailed information. These findings suggest that 18F-FAZA PET could be a valuable tool for better understanding and potentially treating 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4767236/

Performance of 18F-FET versus 18F-FDG-PET for the ... For brain tumor diagnosis, FET-PET performed much better than FDG and should be preferred when assessing a new isolated brain tumor.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6543630/

Technical feasibility of [18F]FET and [18F]FAZA PET guided ... In this study we showed the feasibility of PET guided subvolume boosting of F98 glioblastoma in rats. No evidence was found for a beneficial ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/1724600820905715

18F-FAZA PET imaging in tumor hypoxia: A focus on high- ... In their study, including 50 oncological patients, 7/50 were affected by glioblastoma. The authors reported high tumor-to-blood ratios, mainly ...

4. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2023.1103262/full

PET tracers in glioblastoma: Toward neurotheranostics as ... F-FET PET combined with MRI may improve tumor diagnosis and increase specificity (21). Moreover, amino acid PET tracers provide valuable ...

5. mdpi.com mdpi.com/2079-9721/13/7/215

Optimizing Stereotactic Intracranial Neoplasm Treatment [18F]FET PET has a diagnostic accuracy of 85% for glioblastoma patients in the differentiation of pseudoprogression from effective radiochemotherapy [15]. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2948639/

Biodistribution and dosimetry of 18F-EF5 in cancer patients ... The primary purpose of this study was to assess the biodistribution and radiation dose resulting from administration of 18 F-EF5, a lipophilic 2-nitroimidazole ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/58/8/1224

First Evaluation of PET-Based Human Biodistribution and ... Our dosimetry data showed that a 370-MBq injection of 18F-FAZA is safe for clinical use, similar to other widely used PET ligands. In particular ...

8. mdpi.com mdpi.com/1424-8247/14/8/722

Primary and Metastatic Brain Tumours Assessed with the ... We concluded that the brain and torso [ 18 F]FDG PET/CT study provides valuable data that may support therapeutic management by detecting clinically silent ...

9. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/fmiso-ib.pdf

INVESTIGATOR'S BROCHURE For: The oxygenation status of the tumors was assessed using 18 F-FMISO PET imaging followed by Eppendorf pO2 electrode measurements. Data were compared in a ` ...