Advanced PET/MR Imaging for Breast Cancer

Overseen By Anna Sorace, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: University of Alabama at Birmingham

Must be taking: HER2-targeted treatment

Disqualifiers: Pregnancy, Uncontrolled disorders, Obesity, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

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 trial explores a new imaging test to determine if it can better predict treatment response in stage IV HER2+ breast cancer. The test uses a special substance called [18F]-FDG (a radiotracer) to create detailed images with PET/MRI scans. It targets individuals with stage IV HER2+ breast cancer who have not yet started a specific new treatment plan. Those diagnosed with this type of breast cancer and who have not begun treatment might be suitable for the trial. As a Phase 1, Phase 2 trial, this research aims to understand how the imaging test functions in people and to measure its effectiveness in predicting treatment response, offering participants a chance to contribute to groundbreaking advancements in cancer care.

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 is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that [18F]-FDG, used in PET scans, is generally safe for people. This radioactive substance helps doctors assess how the body's tissues function. It has been used for many years to diagnose various conditions, including breast cancer.

Studies indicate that [18F]-FDG scans can alter treatment plans for breast cancer patients in about 6.5-18% of cases, making it a valuable tool in medical imaging. However, concerns exist about false-positive results, where the scan might suggest a problem when there isn't one, leading to additional testing.

Overall, [18F]-FDG is well-tolerated, and serious side effects are rare. Most people don't experience major issues during scans with this tracer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using [18F]-Fluorodeoxyglucose (FDG) PET/MRI for breast cancer because it combines two powerful imaging techniques—PET and MRI—into one. Unlike traditional imaging options, this approach offers high precision in detecting cancerous tissue and assessing how active the cancer is. This could lead to more accurate diagnoses and better treatment planning, potentially improving outcomes for patients. By visualizing both the structure and metabolic activity of tumors, this method provides a comprehensive view that current imaging options may not fully capture.

What evidence suggests that this imaging technique is effective for identifying response to stage IV HER2+ breast cancer?

Research has shown that [18F]-FDG PET/MRI, the imaging method under study in this trial, excels at detecting certain types of cancer spread. It is particularly effective at identifying cancer that has spread to the liver and possibly the bones in breast cancer patients, outperforming other imaging methods. This suggests it might detect these cancer spreads more frequently. However, it may not be as effective at identifying cancer that has spread to the lungs. Overall, [18F]-FDG PET/MRI is a promising tool for tracking breast cancer spread in the body, potentially aiding doctors in assessing treatment effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Anna Sorace, PhD

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 IV HER2+ breast cancer who haven't started a new HER2-targeted therapy. They must have measurable disease, an expected lifespan over six months, and can be estrogen/progesterone receptor positive or negative. Excluded are those with certain medical conditions, metal in their body incompatible with MRIs, pregnant/breastfeeding women, and anyone unable to lie still for imaging.

Inclusion Criteria

I have HER2+ metastatic breast cancer.

Patients must have one tumor that can be measured according to specific guidelines.

My breast cancer is HER2-positive based on lab tests.

Exclusion Criteria

I have a serious health condition that could affect my participation in the study.

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

I have metastatic breast cancer, am HER2 positive, and have started HER2-targeted treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline imaging using PET/MRI to establish initial metrics

1 week

1 visit (in-person)

Treatment Monitoring

Participants undergo imaging up to three times during therapy to monitor response

6 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in imaging metrics and disease progression

5 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]-FDG

Trial Overview The study tests whether advanced PET/MR imaging using [18F]-FDG can detect early responses to targeted therapy in patients with advanced-stage HER2+ breast cancer before treatment begins.

How Is the Trial Designed?

Group I: [18F]-Fluorodeoxyglucose (FDG) PET/ MRI Experimental Treatment 1 Intervention

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

In a study involving 74 patients with advanced breast and prostate cancers, the combined Na[18F]F/[18F]FDG PET/MRI technique detected significantly more skeletal lesions (140) compared to the standard [99mTc]MDP whole-body bone scintigraphy (81 lesions).

The PET/MRI approach also identified extra-skeletal lesions in 19 patients, suggesting it may provide a more comprehensive assessment of disease spread compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous PET/MRI in the Evaluation of Breast and Prostate Cancer Using Combined Na[18F] F and [18F]FDG: a Focus on Skeletal Lesions. Sonni, I., Minamimoto, R., Baratto, L., et al.[2021]

2-[18F]-FDG is a safe and effective PET radiopharmaceutical used for imaging, with a low dose of 185 to 370 MBq per patient, resulting in a total effective radiation dose of 7.8 to 10 mSv, which is considered low risk for radiation-induced malignancy.

The compound does not interfere with normal glucose metabolism, is retained in cells for several hours after uptake, and is rapidly excreted, making it a reliable tool for diagnostic imaging without significant toxicological concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Toxicity and radiation dosage of 2-(18F)-2-desoxy-D-glucose in positron emission tomography]. Ruhlmann, J., Oehr, P., Bender, H., et al.[2013]

In a study of 45 breast cancer patients, (18)F-FDG PET/CT demonstrated slightly higher accuracy (86.7%) compared to (18)F-NaF PET/CT (84.4%) for detecting bone metastases, indicating its reliability as a diagnostic tool.

While (18)F-FDG PET/CT was generally more effective, (18)F-NaF PET/CT showed superior sensitivity in specific cases, such as detecting sclerotic lesions and in patients with high suspicion of relapse, leading to changes in management for 6.6% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons between glucose analogue 2-deoxy-2-((18)F)fluoro-D-glucose and (18)F-sodium fluoride positron emission tomography/computed tomography in breast cancer patients with bone lesions. Capitanio, S., Bongioanni, F., Piccardo, A., et al.[2020]

In a study of 466 women with ER-positive, HER2-negative breast cancer, higher levels of 18F-fluorodeoxyglucose metabolism (measured by maximum standardized uptake value) were associated with significantly lower distant relapse-free survival (DRFS) and overall survival (OS).

Patients in the low tertile of SUV had an 8-year DRFS rate of 90.7%, while those in the middle and high tertiles had a rate of only 73.7%, indicating that PET/CT imaging can be a valuable tool for assessing the risk of metastasis and mortality in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between tumor 18F-fluorodeoxyglucose metabolism and survival in women with estrogen receptor-positive, HER2-negative breast cancer. Chae, SY., Park, SH., Lee, HS., et al.[2022]

In a study of 179 breast cancer patients, FDG PET/CT scans were able to identify disease recurrence in 63.7% of cases, indicating its effectiveness as a diagnostic tool.

Patients with PET/CT evidence of recurrence had significantly shorter overall survival compared to those without recurrence, highlighting the prognostic value of FDG PET/CT in both luminal A and B breast cancer subtypes, regardless of tumor marker levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on the long-term prognosis of FDG PET/CT in luminal-A and luminal-B breast cancer. Urso, L., Quartuccio, N., Caracciolo, M., et al.[2023]

In a study of 70 patients with primary breast carcinoma, the differential absorption ratio (DAR) calculated from FDG PET scans was found to be a significant prognostic indicator, with higher DAR values correlating to worse overall and relapse-free survival rates.

Patients with a high DAR (≥3.0) had significantly poorer prognoses compared to those with a low DAR (<3.0), highlighting the potential of FDG PET as a tool for predicting outcomes in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the prognoses of breast carcinoma patients with positron emission tomography using 2-deoxy-2-fluoro[18F]-D-glucose. Oshida, M., Uno, K., Suzuki, M., et al.[2022]

The study demonstrated that 18F-FDG can effectively induce cell death in breast cancer tumors, with small tumors showing apoptotic cell death and larger tumors exhibiting necrosis, without damaging normal mammary tissue.

Doses of 18F-FDG up to 5 mCi were found to be non-radiotoxic to healthy organs, suggesting that it could be a safe and effective radiomolecular therapy for breast cancer patients, particularly in cases where standard treatments fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography agent 2-deoxy-2-[18F]fluoro-D-glucose has a therapeutic potential in breast cancer. Moadel, RM., Nguyen, AV., Lin, EY., et al.[2018]

In a study of 100 patients with FDG-avid lymphomas, the analysis of [18F]-FDG-PET/MR data revealed that standardized uptake values (SUVs) and apparent diffusion coefficients (ADCs) are independent biomarkers, indicating they provide different information about the disease.

A significant correlation between ADCmean and SUVmean was found specifically in follicular lymphoma, suggesting that while SUVs and ADCs generally do not correlate, they may have a moderate relationship in this particular subtype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between glycolytic activity on [18F]-FDG-PET and cell density on diffusion-weighted MRI in lymphoma at staging. Giraudo, C., Karanikas, G., Weber, M., et al.[2019]

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]

The synthesis of 2-deoxy-2-[18F]fluoro-D-glucopyranosyl [18F]fluoride was achieved with a radiochemical yield of approximately 28% in a total synthesis time of 70 minutes, indicating a relatively efficient process for producing this compound.

Biodistribution studies in mice showed that the compound defluorinates in vivo to produce 2-deoxy-2-[18F]fluoro-D-glucose and [18F]fluoride, suggesting potential applications in imaging or therapeutic interventions involving glucose metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and biodistribution of 2-deoxy-2-[18F]fluoro-D-glucopyranosyl [18F]fluoride in mice. Shiue, CY., Arnett, CD., Wolf, AP.[2019]

FDG-PET/CT is an effective imaging tool that combines metabolic and anatomical data, enhancing the diagnosis and management of breast cancer and other tumors in a single session.

This imaging technique is valuable for various stages of cancer management, including diagnosis, staging, treatment response assessment, and evaluating metastatic disease, although it also has some limitations that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present and future role of FDG-PET/CT imaging in the management of breast cancer. Kitajima, K., Miyoshi, Y.[2022]

2-Deoxy-2-[(18)F]fluoro-D-glucose (2-(18)FDG) is a highly effective PET tracer used in various medical fields, including oncology and cardiology, due to its ability to reflect glucose metabolism and disease progression.

Several new radiofluorinated carbohydrates, such as 2-deoxy-2-[(18)F]fluoro-D-galactose and 6-deoxy-6-[(18)F]fluoro-D-fructose, show promise for diagnosing specific conditions like liver cancer and breast cancer, indicating potential for further development in medical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofluorinated carbohydrates for positron emission tomography. Mun, J.[2019]

6-[(18)F]FDF, a new PET radiotracer, shows promise for imaging GLUT5 expression in breast cancer, demonstrating significant uptake in breast cancer cells independent of glucose levels, which could improve detection compared to traditional [(18)F]FDG.

In vivo studies revealed that 6-[(18)F]FDF accumulates effectively in EMT-6 tumors, suggesting its potential as a more specific imaging agent for certain breast cancers, particularly those expressing GLUT5 and ketohexokinase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiopharmacological evaluation of 6-deoxy-6-[18F]fluoro-D-fructose as a radiotracer for PET imaging of GLUT5 in breast cancer. Wuest, M., Trayner, BJ., Grant, TN., et al.[2016]

Citations

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Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... Our meta-analysis indicates that [ 18 F]FDG PET/MRI demonstrates superior sensitivity and similar specificity to [ 18 F]FDG PET/CT in detecting bone metastases ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5028256/

Comparison of Whole-Body 18F FDG PET/MR Imaging and ... In patients with breast cancer, PET/MR imaging may yield better sensitivity for liver and possibly bone metastases but not for pulmonary metastases, as compared ...

3. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01830-5

[18F]FDG whole-body PET-MR including an integrated breast ... Results of [18F]FDG WB PET-MR, including integrated breast MR, versus conventional imaging modalities were compared. Results. From April 2021– ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-10175

18F-FDG and Fluorine F18 FDHT PET/MRI Imaging in ... This early phase I trial tests whether positron emission tomography/magnetic resonance imaging (PET/MRI) scans using the imaging agent F18-FDHT are an ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820924002726

Review Article Comparison of [ 18 F] FDG PET/CT and ... This meta-analysis aims to assess and compare the diagnostic effectiveness of [ 18 F]FDG PET/CT and [ 18 F]FDG PET/MRI for distant metastases in breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8458550/

Benefits and harms of implementing [18F]FDG-PET/CT for ... Data are scarce on the extent and clinical consequences of false-positive incidental findings on [18F]FDG-PET/CT in women suspected of recurrent breast cancer.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557653/

Fludeoxyglucose (18F) - StatPearls - NCBI Bookshelf - NIH Fludeoxyglucose F18 is a radioactive tracer that acts as a glucose analog and is used for diagnostic purposes in conjunction with positron-emitting tomography ...

8. mdpi.com mdpi.com/2075-4418/11/11/1954

Diagnostic Performance of [18F]FDG PET in Staging Grade ... In addition, various studies have shown that FDG PET outcomes affected the treatment plan in 6.5–18% of patients with primary breast cancer [11,15,29]. These ...

9. ejhi.springeropen.com ejhi.springeropen.com/articles/10.1186/s41824-018-0039-x

Positron emission tomography in breast cancer: 18F- FDG and ... In the current study, we will review the utility of the most widely used molecular imaging technique, 18 F-fluorodeoxyglucose ( 18 F-FDG) PET.

10. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.220143

18F-Fluoroestradiol: Current Applications and Future ... 18 ( 18 F) fluoroestradiol (FES) for clinical use in patients with ER-positive recurrent or metastatic breast cancer as an adjunct to biopsy.