Trial Outcomes & Findings for Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis (NCT NCT01852032)

Results Overview

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Day 1

Results posted on

2018-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Breast Cancer Patients Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Age, Customized greater than 35 years old	23 participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Participants with suspected breast cancer

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Outcome measures

Outcome measures
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Beta of CT Coronal View	1.75 power-law slope(B) Standard Deviation 0.424

PRIMARY outcome

Timeframe: Day 1

Population: Participants with suspected breast cancer

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Outcome measures

Outcome measures
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Beta of CT Sagittal View	1.83 power-law slope(B) Standard Deviation 0.352

PRIMARY outcome

Timeframe: Day 1

Population: Participants with suspected breast cancer

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Outcome measures

Outcome measures
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Beta of CT Axial View	1.79 power-law slope(B) Standard Deviation 0.397

PRIMARY outcome

Timeframe: Day 1

Population: Participants with suspected breast cancer

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Outcome measures

Outcome measures
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Beta of Tomosynthesis Craniocaudal View	3.06 power-law slope(B) Standard Deviation 0.361

PRIMARY outcome

Timeframe: Day 1

Population: Participants with suspected breast cancer

frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).

Outcome measures

Outcome measures
Measure	Breast Cancer Patients n=23 Participants Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Beta of Tomosynthesis Medial Lateral Oblique View	3.10 power-law slope(B) Standard Deviation 0.315

Adverse Events

Breast Cancer Patients

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

John Brock Staff Research Associate

UC Davis

Phone: 916-734-3101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place