Trial Outcomes & Findings for Evaluation of Breast CT (NCT NCT00584233)

Last Updated: 2022-12-06

Results Overview

The specific quantitative endpoint of the analysis is the difference in area under the receiver operating characteristic curve (AUC) between contrast-enhanced breast CT (CE-bCT) and contrast-enhanced breast MRI (CE-bMRI).

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

5 years

Results posted on

2022-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Breast CT and Breast MRI Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging. computed tomography: Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL). MRI: Breast MRI
Overall Study STARTED	75
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Breast CT and Breast MRI Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging. computed tomography: Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL). MRI: Breast MRI
Overall Study Withdrawal by Subject	5
Overall Study Subjects did not complete both CT and MRI to be evaluated in results	13

Baseline Characteristics

Evaluation of Breast CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast CT and Breast MRI n=57 Participants Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging. computed tomography: Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL). MRI: Breast MRI
Age, Continuous	57 years n=93 Participants
Sex: Female, Male Female	57 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	45 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The analysis patient population includes women characterized as BIRAD's 4 and 5 patients based upon screening mammography (or tomosynthesis), who will then undergo further imaging workup based upon a positive finding on screening mammography (or tomosynthesis) or a palpable lesion. Because these women will be having a breast needle core biopsy after imaging, the lesion histopathology will be known and we can classify patients as having either benign or malignant lesions.

Outcome measures

Outcome measures
Measure	Breast CT and Breast MRI n=57 Participants Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging. computed tomography: Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL). MRI: Breast MRI
Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.	-0.04 probability Standard Error 0.02

Adverse Events

Breast CT and Breast MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Boone

University of California Davis

Phone: (916) 849-3580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place