Dedicated Breast CT for Diagnosis of Breast Cancer

Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer

Detailed Description

Rationale:

Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.

Objective:

The primary objective of this research project is to determine the improvement in the area under the receiver operating characteristics (ROC) curve of BCT for diagnosis of breast cancer compared to that of the standard diagnostic work-up. As secondary objectives, this analysis will be performed by lesion type (microcalcifications vs. soft tissue lesions).

Study design:

Single arm study with each subject being its own control

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Netherlands Cancer Institute
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population base consists of women recalled to undergo diagnostic work-up due to a suspicious finding at mammographic screening for breast cancer.

Description

Inclusion Criteria:

• Women age 50 or older

Initial schema:

- Women who are scheduled to undergo a diagnostic work-up following an abnormal screening mammogram with the suspicious finding NOT located in the axillary tail of the breast This initial inclusion criterion will be used until 85 subjects that result in a Breast Imaging Reporting and Data System (BI-RADS) 1 or 2 after clinical diagnostic work-up are recruited and imaged.

Subsequent schema:

- Women who underwent diagnostic work-up following an abnormal screening mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions (total 120 patients when combined with those from the initial schema), or due to microcalcifications (total 120 patients when combined with those from the initial schema) with the suspicious finding NOT located in the axillary tail of the breast

Each patient can only enroll once in the study.

Exclusion Criteria:

• Women who do not meet the inclusion criteria as described above
• Women with suspected or confirmed pregnancy
• Women who have had bilateral mastectomy
• Women whose suspicious lesion is located in the axillary tail
• Women with prior breast cancer or breast biopsy in the recalled breast in the last 12 months
• Women who are breastfeeding
• Women who are very frail and unable to cooperate
• Women who cannot give informed consent
• Male subjects

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of malignancy (POM)	The primary objective of this study is to perform a prospective clinical trial to compare the performance of BCT and US (for soft tissue lesions) to that of the standard diagnostic work-up (several mammographic views and US for soft tissue lesions) for the diagnosis of breast cancer. The endpoint is the area under the receiver operating characteristic (ROC) curve (AUC) computed from probability of malignancy (POM) resulting from independent interpretation of the clinical diagnostic work-up images and the BCT images as produced by the BCT system + US (when acquired during standard clinical diagnostic workup).	One year after the end of participation in this study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of malignancy (POM)	The secondary objective, a comparison is made among the clinical diagnostic work-up, the BCT images as produced by the system alone, and the BCT images enhanced using our novel algorithms alone. The endpoint is the area under the receiver operating characteristic (ROC) curve (AUC) computed from probability of malignancy (POM) resulting from independent interpretation images.	One year after the end of participation in this study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant characteristics	Participant characteristics such as age, gender, ethnicity, race, cup size, reason of referral, family history for breast cancer, level of comfort during BCT examination and level of comfort of BCT compared to other image modality.	Day of participation

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2016
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Computed Tomography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NL55378.091.15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No