Low-Dose High-Resolution Breast CT for Breast Cancer

(LowerDoseBCT Trial)

Overseen By Michele Galvan, R.T.R.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Males, Under 40, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breast imaging method called breast CT (BCT) to determine if it helps doctors identify breast cancer more accurately. The goal is to enhance image clarity so doctors can detect small changes in breast tissue. Women aged 40 or older, scheduled for breast imaging or needing a biopsy, are suitable candidates for this study. Participants will undergo a breast CT scan, which uses a special dye (iodinated contrast agent) to highlight breast tissues. As an unphased study, this trial allows participants to contribute to advancements in breast cancer detection technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that contrast-enhanced breast CT (CE-BCT) is generally safe for imaging. Studies on similar methods, such as contrast-enhanced mammography, have indicated that these techniques effectively detect breast cancer. They use iodine-based contrast agents, which are safe for most individuals.

However, a small risk of allergic reactions exists. Most reactions are mild, but some can be more serious, though rare. Overall, evidence suggests that contrast agents in breast imaging are well-tolerated, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-dose high-resolution breast CT, known as contrast-media enhanced breast CT (CE-BCT), because it offers a potentially clearer and more detailed view of breast tissue than traditional mammograms. Unlike standard mammography, which can sometimes struggle to detect cancer in dense breast tissue, CE-BCT uses advanced imaging techniques to provide a three-dimensional, high-resolution image. This method enhances the visibility of tumors, potentially leading to earlier and more accurate detection of breast cancer. The use of contrast media further improves the differentiation between cancerous and non-cancerous areas, helping doctors make more informed decisions.

What evidence suggests that this breast CT is effective for breast cancer diagnosis?

Research has shown that contrast-enhanced breast CT (CE-BCT), which participants in this trial will undergo, can help doctors detect breast cancer earlier, especially in women with dense breast tissue. Studies have found that adding contrast imaging increases the rate of early cancer detection. For instance, one study reported a 13% increase in finding early breast cancer with this method. Detecting cancer early is crucial because it greatly improves the chances of successful treatment and survival. Overall, CE-BCT appears promising in providing more accurate and earlier breast cancer diagnoses. ^{1 3 4 6 7}

Who Is on the Research Team?

Srinivasan Vedantham, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for women over 40 who've had a suspicious breast screening result (BI-RADS category 4 or 5) and no known allergies to iodinated contrast media. It's not for those unable to consent, with physical limitations, over the BCT table weight limit of 440 lbs, prior thorax radiation treatment, impaired kidney function, history of excessive diagnostic x-rays, men, under age 40, prisoners or pregnant/breastfeeding women.

Inclusion Criteria

Patients who have no known adverse reaction to iodinated contrast media

Patients who were assigned BI-RADS category 4 or 5 after x-ray based diagnostic work-up such as mammography or digital breast tomosynthesis (DBT)

I meet the requirements for CT scans with contrast at UA-BUMC.

Exclusion Criteria

I have been in a breast study before that involved extra radiation.

I am allergic to contrast dye used in medical imaging.

My kidney function is low, with a GFR under 30 mL/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo bilateral breast CT imaging exam to create a 3-D image of the breast

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic accuracy and contrast enhancement quantification

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Contrast-media enhanced breast CT(CE-BCT)
• Iodinated Contrast Agent

Trial Overview

The study tests if a new type of breast imaging called dedicated breast CT (BCT) can better reveal small structures in the breast tissue and improve accuracy in diagnosing breast cancer compared to traditional methods like mammography.

How Is the Trial Designed?

Group I: Dedicated breast computed tomography (BCT) Experimental Treatment 1 Intervention

All subjects will undergo bilateral breast CT (BCT) imaging exam.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A dedicated breast CT system has been developed and tested on 55 women, showing excellent anatomical detail and visualization of tumors, especially when using iodine contrast, which enhances tumor detection.

The breast CT system is designed to use radiation doses comparable to standard two-view mammography, making it a potentially safe alternative for breast cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography for imaging the breast. Boone, JM., Kwan, AL., Yang, K., et al.[2019]

In a study of female patients over 40 with malignant breast lesions, contrast enhancement on cone-beam breast-CT (CBBCT) was found to significantly differentiate between breast cancer subtypes, with Luminal A lesions showing the highest contrast enhancement compared to other subtypes.

The study suggests that CBBCT could be a useful tool in personalizing treatment strategies for breast cancer patients, as the level of contrast enhancement correlates with immunohistochemical subtype and the proliferative potential of the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast Enhancement on Cone-Beam Breast-CT for Discrimination of Breast Cancer Immunohistochemical Subtypes. Uhlig, J., Fischer, U., von Fintel, E., et al.[2020]

Citations

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Are Iodine-Based Contrasts in Breast Imaging Riskier Than ...

Contrast-enhanced mammography (CEM) and dedicated breast computed tomography (dBCT) are advanced breast imaging techniques that utilize ...