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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.

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.

Is Advanced PET/MRI Imaging for Breast Cancer safe for humans?

The safety of PET imaging with various radiopharmaceuticals, including those similar to [18F]FMISO, has been evaluated in clinical studies for different conditions, showing it to be generally safe for human use. ^{1 2 3 4 5}

How does the Advanced PET/MRI Imaging treatment for breast cancer differ from other treatments?

The Advanced PET/MRI Imaging treatment for breast cancer is unique because it combines metabolic and functional data from PET with detailed anatomical information from MRI in a single session. This approach provides comprehensive insights into tumor metabolism, anatomy, and function, potentially allowing for more precise and less invasive treatment planning compared to traditional imaging methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment [18F]FMISO-PET with contrast-enhanced MRI for breast cancer?

Research shows that PET/MRI, which combines detailed images from MRI with metabolic information from PET scans, is valuable for diagnosing and monitoring breast cancer. It helps in understanding tumor characteristics and predicting outcomes, which can guide personalized treatment plans. ^{6 7 8 9 11}

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

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]

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, 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. England pubmed.ncbi.nlm.nih.gov

Clinical advances in PET-MRI for breast cancer. [2023]

2. England 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. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Towards a fast PET/MRI protocol for breast cancer imaging: maintaining diagnostic confidence while reducing PET and MRI acquisition times. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

MRI fused with prone FDG PET/CT improves the primary tumour staging of patients with breast cancer. [2020]

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

A Role of PET/MR in Breast Cancer? [2022]

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

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

7. United States 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. [2022]

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

PET/MRI radiotracer beyond ¹⁸F-FDG. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Q.Clear reconstruction for reducing the scanning time for 68&#160;Ga-DOTA-FAPI-04 PET/MR imaging. [2023]

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

Simultaneous FAPI PET/MRI Targeting the Fibroblast-Activation Protein for Breast Cancer. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Potential Clinical Applications of 18F-Fluorodeoxyglucose Positron Emission Tomography/Magnetic Resonance Mammography in Breast Cancer. [2020]