Low-Dose High-Resolution Breast CT for Breast Cancer

(LowerDoseBCT Trial)

Overseen By Michele Galvan

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

Trial Summary

What is the purpose of this trial?

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

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 data supports the effectiveness of the treatment Contrast-media enhanced breast CT (CE-BCT) for breast cancer?

Research shows that using iodine-based contrast agents in breast CT scans helps to better highlight tumors, similar to how they are enhanced in MRI scans. This improved visibility can aid in determining the extent of breast cancer, selecting appropriate treatments, and assessing the spread to lymph nodes. ^{1 2 3 4 5}

Is Low-Dose High-Resolution Breast CT safe for humans?

The available research does not provide specific safety data for Low-Dose High-Resolution Breast CT, but it does mention the use of iodine-based contrast agents, which are commonly used in medical imaging and generally considered safe for most people. However, individual reactions can vary, and it's important to discuss any concerns with a healthcare provider. ^{2 6 7 8 9}

How is the treatment Contrast-media enhanced breast CT (CE-BCT) different from other breast cancer treatments?

Contrast-media enhanced breast CT (CE-BCT) is unique because it uses a special iodine-based contrast agent to improve the visibility of tumors in 3D images, making it particularly effective for detecting cancer in dense breast tissue compared to traditional mammography. This method provides high-resolution images with the same radiation dose as standard mammography, offering a promising alternative for breast cancer imaging. ^{1 2 6 10 11}

Research Team

Srinivasan Vedantham, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Contrast Enhancement on Cone-Beam Breast-CT for Discrimination of Breast Cancer Immunohistochemical Subtypes. [2020]

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

Model observer performance in contrast-enhanced lesions in breast CT: The influence of contrast concentration on detectability. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

The role of computed tomography in the selection of breast cancer treatment. [2019]

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

Contrast-enhanced cone beam breast CT features of breast cancers: correlation with immunohistochemical receptors and molecular subtypes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Correlation between contrast-enhanced cone-beam breast computed tomography features and prognostic staging in breast cancer. [2023]

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

Review of clinical studies and first clinical experiences with a commercially available cone-beam breast CT in Europe. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Cone-Beam Breast CT: An Analysis of Diagnostic Value in Predicting Breast Lesion With Rim Enhancement Malignancy. [2022]

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

Dosimetric characterization of a dedicated breast computed tomography clinical prototype. [2021]

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

Investigation of spectral performance for single-scan contrast-enhanced breast CT using photon-counting technology: A phantom study. [2021]

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

Computed tomography for imaging the breast. [2019]

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

Contrast-enhanced cone-beam breast-CT (CBBCT): clinical performance compared to mammography and MRI. [2020]