What is the mechanism of action of this treatment?

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation therapy uses high-energy rays to destroy cancer cells in a specific area. Chemotherapy involves drugs that kill rapidly dividing cells throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain types of breast cancer. Targeted therapy, such as HER2 inhibitors, specifically attacks cancer cells with certain markers. Advanced imaging techniques like KBCT enhance the precision of these treatments by providing detailed 3D images, allowing for more accurate detection, diagnosis, and monitoring of breast cancer, ultimately improving treatment outcomes and reducing unnecessary interventions.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy and chemotherapy, are associated with several side effects. Radiation therapy can lead to acute toxicities like skin irritation, fatigue, and changes in breast appearance, while long-term effects may include cardiopulmonary issues such as dyspnea and fatigue. Chemotherapy often results in side effects like nausea, hair loss, fatigue, and increased risk of infections. Advanced imaging techniques like KBCT are primarily diagnostic and generally have fewer side effects, but they are crucial for detailed breast examination and treatment planning.

What prior FDA approvals exist?

The FDA has approved several advanced imaging techniques for breast cancer diagnosis and treatment monitoring, including digital mammography, MRI, and PET/CT scans. These imaging modalities provide detailed visualization of breast tissue, aiding in early detection and treatment planning. Additionally, the FDA has approved various targeted therapies and chemotherapeutic agents for breast cancer, such as trastuzumab (Herceptin) and its biosimilars, which are used in combination with imaging tools to monitor treatment efficacy and disease progression.

What other types of research exist?

Promising novel alternatives to KBCT for breast cancer patients include: 1) Cone Beam Breast CT, which provides high-resolution 3D imaging and is being evaluated for its effectiveness in screening and diagnostic settings. 2) Hybrid Fluorescence Molecular Tomography-X-ray Phase-Contrast CT (FMT-PCCT), which combines molecular imaging with high-contrast anatomical imaging, potentially offering superior lesion detection and characterization. 3) Whole-body low-dose multidetector row-CT (MDCT), which, although primarily used for other cancers, shows potential for comprehensive imaging with lower radiation doses.

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Imaging

Cone Beam CT for Breast Cancer Screening

N/A

Recruiting

Research Sponsored by Koning Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnostic Group: Female sex of any ethnicity, Age 20 years or older, Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality, Will undergo diagnostic mammography, prior to breast biopsy (if needed)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after the cbbct imaging and mammography imaging

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special 3D breast scan called KBCT to get detailed images of the breast. It targets women aged 40 and above who are undergoing routine breast checks. The scan takes many pictures from different angles to create a clear 3D image, helping doctors see any problems more easily.

Who is the study for?

This trial is for women seeking breast cancer screening or diagnostic workup. Eligible participants are over 40 years old for routine screening, or over 20 with detected abnormalities for diagnostics. Exclusions include lactation, physical limitations, excessive prior x-rays, pregnancy without testing consent, inability to understand the study, and previous radiation treatments.

What is being tested?

The trial is evaluating Cone Beam Breast CT (CBBCT) imaging against standard Digital Mammography in detecting breast cancer. Up to 1028 women will undergo CBBCT scans within four weeks of their mammogram before any potential biopsy to compare effectiveness.

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects from such imaging tests may include discomfort during the procedure and exposure to low levels of radiation which carries a small risk of harmful effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 20, found a breast abnormality, and will have a mammogram before any biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after cbbct image review and mammography image review

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after cbbct image review and mammography image review

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after cbbct image review and mammography image review for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiation Dose

Recall Rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CBBCT Imaging Screening PatientsExperimental Treatment2 Interventions

Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of screening mammography.

Group II: CBBCT Imaging Diagnostic PatientsExperimental Treatment2 Interventions

Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of diagnostic mammography.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation therapy uses high-energy rays to destroy cancer cells in a specific area. Chemotherapy involves drugs that kill rapidly dividing cells throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain types of breast cancer. Targeted therapy, such as HER2 inhibitors, specifically attacks cancer cells with certain markers. Advanced imaging techniques like KBCT enhance the precision of these treatments by providing detailed 3D images, allowing for more accurate detection, diagnosis, and monitoring of breast cancer, ultimately improving treatment outcomes and reducing unnecessary interventions.

[Radiation therapy after mastectomy--interdisciplinary consensus puts and end to a controversy. German Society of Senology].