Trial Outcomes & Findings for Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis (NCT NCT00610467)

Results Overview

ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

After we meet the enrollment target

Results posted on

2020-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Disease Group Patients with suspicious breast diseases	Control Group Healthy volunteers for system testing
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disease Group n=1 Participants Patients with suspicious breast diseases	Control Group n=1 Participants Healthy volunteers for system testing	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: After we meet the enrollment target

Population: We had performed the combined MRI and optical imaging on two subjects. Due to the small sample size, there is low statistical power to conclude any findings. Study was terminated pre-maturely. All files have been destroyed per IRB requirement. No outcome measure data are available.

ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT

Outcome measures

Outcome data not reported

Adverse Events

Disease Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Professor

University of California Irvine

Phone: 949-824-6001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place