Dedicated Breast CT for Diagnosis of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Dedicated Breast CT for Diagnosis of Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05458427
• Other study ID #: NL55378.091.15
• Status: Terminated
• Start date: October 21, 2016
• Est. completion date: January 9, 2024

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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