Advanced PET/MRI Imaging for Breast Cancer

Overseen By Sebastian Eady

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Immunotherapy

Disqualifiers: Pregnancy, Metal implants, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging technique using [18F]FMISO-PET (a type of positron emission tomography scan) and MRI can track and predict the effectiveness of immunotherapy for individuals with triple-negative breast cancer, a type of breast cancer lacking certain hormone receptors. It will not alter any current treatment plans but could guide future research. The trial seeks patients with biopsy-proven triple-negative breast cancer who have not yet started immunotherapy and have a measurable tumor. Participants will need to attend several imaging visits, including one before beginning their immunotherapy. As an Early Phase 1 trial, this research focuses on understanding how the imaging technique functions in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on imaging and does not change your treatment plan, which is determined by your oncologist.

What prior data suggests that this imaging technique is safe for breast cancer patients?

Research has shown that [18F]FMISO, a substance used in PET scans, is generally safe for people. In medical use, it has been administered without serious issues. Studies suggest no expected side effects from administering [18F]FMISO through an IV for typical PET scans. Patients have not reported major side effects in past studies, indicating that the procedure is well-tolerated. Although this is an early phase trial, existing evidence supports the safety of [18F]FMISO for imaging purposes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new imaging technique using [18F]FMISO-PET coupled with contrast-enhanced MRI to better understand breast cancer. Unlike standard imaging methods, this approach could provide more detailed insights into tumor biology by highlighting areas of low oxygen (hypoxia) within the tumor. This could potentially lead to more personalized treatment plans and improve monitoring of treatment response, offering a significant advancement in breast cancer management.

What evidence suggests that this imaging technique is effective for monitoring triple negative breast cancer?

Research has shown that a special imaging technique called [18F]FMISO-PET, when combined with MRI, can effectively examine breast cancer. This method identifies areas in tumors with low oxygen, known as hypoxia, which is significant because these tumors can be more aggressive. In this trial, participants will undergo [18F]FMISO-PET with contrast-enhanced MRI to obtain detailed images showing both the tumor's blood supply and oxygen levels. This approach can be particularly useful for patients receiving immunotherapy, as it might help predict the treatment's effectiveness. While promising, the current evidence remains preliminary, and further research is needed to confirm its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Janis O'Malley, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with stage II-IV triple negative breast cancer who are eligible for immunotherapy but haven't started it yet. They must have a lesion over 1 cm, not be pregnant or breastfeeding, and have good kidney function. It's not for those unable to consent, with MRI contraindications like certain metal implants or tattoos, allergies to gadolinium contrast agents, previous immunotherapy treatment, or if they weigh over 350 lbs.

Inclusion Criteria

Must not be pregnant or breastfeeding

I have stage II-IV triple negative breast cancer.

My kidney function tests are within normal limits.

Exclusion Criteria

I cannot stay still for an hour on an imaging table.

Lactating, known or suspected pregnancy. Women with child-bearing potential must have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study

Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Imaging Visit #1

Participants undergo baseline PET/MRI imaging before starting immunotherapy

4 hours

1 visit (in-person)

Imaging Visit #2

Participants undergo PET/MRI imaging after the 1st cycle of immunotherapy and before the 2nd cycle

4 hours

1 visit (in-person)

Imaging Visit #3

Participants undergo PET/MRI imaging after the 2nd cycle of immunotherapy and before the 4th cycle

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for up to 5 years or until disease progression by reviewing medical records

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FMISO-PET with contrast-enhanced MRI

Trial Overview [18F]FMISO-PET combined with contrast-enhanced MRI is being tested in this study of 20 patients to see how well it can monitor the effects of immunotherapy on breast cancer without influencing treatment decisions. The imaging results may help design future larger trials.

How Is the Trial Designed?

Group I: Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR) Experimental Treatment 1 Intervention

The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) \[18F\]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes. The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

This pilot study involving nine breast cancer patients demonstrated that sequential multiparametric 18[F]FDG/[18F]FMISO PET-MRI can effectively assess tumor heterogeneity and correlate with important prognostic indicators, such as tumor proliferation and recurrence risk.

Strong correlations were found between PET imaging parameters and clinical outcomes, particularly with disease-specific death and metastasis, suggesting that this imaging technique could enhance precision medicine approaches in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential [18F]FDG-[18F]FMISO PET and Multiparametric MRI at 3T for Insights into Breast Cancer Heterogeneity and Correlation with Patient Outcomes: First Clinical Experience. Andrzejewski, P., Wengert, G., Helbich, TH., et al.[2020]

PET-MRI is a promising hybrid imaging technology that combines metabolic and functional data from PET with detailed anatomical information from MRI, enhancing the early detection and clinical staging of breast cancer.

Ongoing research into targeted radiopharmaceuticals and automated analysis tools is expected to improve the effectiveness of PET-MRI in diagnosing, staging, and monitoring treatment responses in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical advances in PET-MRI for breast cancer. Fowler, AM., Strigel, RM.[2023]

PET/MRI, introduced in 2010, combines high-resolution MRI with metabolic PET data, showing high diagnostic value for whole-body cancer staging, particularly in breast cancer.

This imaging modality improves detection of distant metastases and lymph node involvement, potentially allowing for less invasive treatments and reducing the need for extensive surgeries like mastectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Role of PET/MR in Breast Cancer? Bruckmann, NM., Morawitz, J., Fendler, WP., et al.[2022]

Positron emission tomography/computed tomography (PET/CT) is a rapidly growing imaging technique in cancer management, but the commonly used radiotracer [(18)F]fluorodeoxyglucose (FDG) is not specific for malignant disease, highlighting the need for more tumor-specific PET radiopharmaceuticals.

Over the past 15 years, various alternative (18)F-labeled radiotracers have been developed and evaluated, which may provide better characterization of tumor biology, emphasizing the importance of regulatory compliance and safety in their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. Vallabhajosula, S.[2022]

The second phase 3 clinical trial of Fluorine-18 Flurpiridaz PET myocardial perfusion imaging (MPI) aims to assess its effectiveness in diagnosing significant coronary artery disease (CAD) in patients suspected of having the condition, using invasive coronary angiography as the gold standard.

This study will also compare the diagnostic efficacy of F-18 Flurpiridaz PET MPI to the traditional Tc-99m-labeled SPECT MPI, particularly in specific subgroups such as females, obese patients, and diabetics, providing a comprehensive evaluation of its performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. Bourque, JM., Hanson, CA., Agostini, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6341235/

Sequential [18F]FDG-[18F]FMISO PET and Multiparametric ... We demonstrated the feasibility and potential of multiparametric [18F]FDG/[18F]FMISO PET-MRI in breast cancer patients. Our pilot study showed ...

2. withpower.com withpower.com/trial/early-phase-1-triple-negative-breast-neoplasms-7-2021-57b04

Advanced PET/MRI Imaging for Breast Cancer Trial Overview [18F]FMISO-PET combined with contrast-enhanced MRI is being tested in this study of 20 patients to see how well it can monitor the effects of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10415421/

PET/MRI of hypoxia and vascular function in ER-positive ... Hypoxia measured by [ 18 F]-FMISO-PET was associated with increased CAIX expression, low MVD, and smaller vessel diameters in ER + breast cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04861077

Monitoring Breast Cancer Immunotherapy Treatment With ... This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2012.30.15_suppl.10512

Dynamic contrast-enhanced MRI versus 18F-misonidazol ... Results: After only one administration of bev, tumor proliferation and perfusion assessed using FLT-PET and DCE-MRI significantly decrease (-26% and -46%, p< ...

6. withpower.com withpower.com/trial/phase-1-breast-neoplasms-11-2021-eef33

Advanced PET/MRI Imaging for Breast Cancer Preliminary studies suggest that [18F]FMISO, a tracer used in PET imaging, may be safe for use in humans, as it has been used in clinical applications for ...

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

INVESTIGATOR'S BROCHURE For: Thus no adverse effects are expected as a result of the IV administration of [18F]FMISO for typical PET imaging. Page 18. Investigator's Brochure: [18F]FMISO.

8. mdpi.com mdpi.com/2075-4418/13/4/597

The Role of PET/CT in Breast Cancer This review discusses the role of 18 F-FDG PET and other PET tracers beyond FDG in breast cancer imaging.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354408/

Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... In diagnosing recurrence in breast cancer at the patient level, [18F]FDG PET/CT demonstrated a pooled sensitivity of 0.93 (95% CI: 0.88–0.96), ...