Trial Outcomes & Findings for Tactile Breast Imaging Sensor for Tumor Malignancy Characterization (NCT NCT02603211)

NCT ID: NCT02603211

Last Updated: 2019-07-26

Results Overview

We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-07-26

Participant Flow

Participant milestones

Measure	Women With Breast Tumors Women with breast tumors. tactile imaging sensor or system made in our laboratory: This is a camera with elastomer tip and LED lights. It is a harmless device.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tactile Breast Imaging Sensor for Tumor Malignancy Characterization

Baseline characteristics by cohort

Measure	Women With Breast Tumors n=20 Participants Women with breast tumors. Tactile imaging sensor or system made in our laboratory: This is a camera with elastomer tip and LED lights. It is a harmless device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.

Outcome measures

Measure	Women With Breast Tumors n=20 Participants Women with breast tumors, who come for biopsy are recruited for this study.
Size Error in Millimeters	0 milimeters Standard Error 5

SECONDARY outcome

Timeframe: 1 year

The tumor risk score is calculated from the tumor size and deformation index. The scale will be from 0 to 5. With 0 being likely to be benign and 5 being likely to be malignant.

We weigh the size 30% and deformation index 70% to come with the risk score. The tumor size is given in millimeters and deformation index is unitless.

Deformation Index represents the hardness of the tumor. The amount at which the probe tip gets deformed by applying a force is called deformation index.

Under the condition that the applied force, depth of the tumor and size of the tumor phantom are kept constant, the softer tumor makes the probe tip deform less than the stiffer tumor. Hence the deformation index for stiffer inclusion will be higher than the softer tumors.

Outcome measures

Measure	Women With Breast Tumors n=20 Participants Women with breast tumors, who come for biopsy are recruited for this study.
Malignancy Estimation Using Risk Score	2.0 participants

Adverse Events

Women With Breast Tumors

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

Chang-hee Won

Temple University

Phone: 2152046158

Email: cwon@temple.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place