Clinical trial NCT05458427: Dedicated Breast CT for Diagnosis of Breast Cancer
Official title: Dedicated Breast CT for Diagnosis of Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Breast Cancer
Computed Tomography
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 210
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Probability of malignancy (POM)
timeFrame: One year after the end of participation in this study
Secondary outcomes:
measure: Probability of malignancy (POM)
timeFrame: One year after the end of participation in this study
Other outcomes:
measure: Participant characteristics
timeFrame: Day of participation
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
References: