Dedicated Breast CT for Diagnosis of Breast Cancer

NCT05458427 | Terminated

• 1 other identifier: NL55378.091.15
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Probability of malignancy (POM)

  One year after the end of participation in this study

Other Outcomes (1)

• Participant characteristics

  Day of participation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women age 50 or older
• Initial schema:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 14, 2022
• Study Start: October 21, 2016
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: February 26, 2024

Record last verified: 2023-11

Locations

NL (2)