An observational study in Breast Cancer, sponsored by Temple University. Completed. Open to female participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Temple University · Observational
The aim of this study is to see how well a tactile imaging sensor will detect for breast masses compared to traditional mammography and/or ultrasound. This device may allow a simple, convenient method to screen for breast tumors. This data will be used to check the feasibility of using the device to detect breast tumors.
The tactile imaging sensor will estimate the relative size and elasticity of the mass(es). This device may allow a simple, convenient method to screen for breast tumors. This is not a treatment and it will not be used to diagnose abnormal masses. The investigators will also not look for any unknown masses. And only doctors will touch the patients. An engineering assistant will be in the room to operate the tactile imaging sensor.
The breast scan that is done as part of this research protocol is not intended to detect any breast disease or abnormality. Research breast scans are not examined by a clinical radiologist to look for abnormalities. Research scan will be evaluated by the engineers developing the device to assess its usefulness. The breast scan for this research will only look at a portion of your breast as it relates to this research. The investigators, the tactile imaging sensor operators and other members of the research team are not qualified to interpret the scan for any diagnostic or therapeutic value. Therefore, the tactile imaging scan being done for this research study will not be analyzed to detect any medical condition.
Patients will have done mammography or ultrasound by now. Once the doctor decides to perform biopsy, the tactile imaging will be planned. The consent will be obtained before the biopsy. One of the investigators (Dr. Caroline or Dr. Reilly) will obtain the consent. Before the biopsy, the doctor will identify the mass(es) using other modalities such as a ultrasound. The tactile imaging sensor operator will obtain the tactile images. Then the biopsy will be performed. Radiology doctor, resident, and radiology technologist are always present during the procedure. In addition a professional assistant from the engineering group will operate the tactile imaging sensor. That person will not have any physical contact with you. The procedure will be very similar to the ultrasound device.
The images will be analyzed by the investigators.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women who had mammogram and are getting biopsy.
Exclusion Criteria:
Women with breast tumors.
Device: tactile imaging sensor or system made in our laboratory
This is a camera with elastomer tip and LED lights. It is a harmless device.
Also known as: mechanical property estimation device, tactile sensor
Size Error in Millimeters
We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.
Time frame: 1 year
Malignancy Estimation Using Risk Score
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.
Time frame: 1 year
| Milestone | Women With Breast Tumors |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.
| milimeters | Women With Breast Tumors |
|---|---|
| Size Error in Millimeters | 0 ± 5 |
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.
| participants | Women With Breast Tumors |
|---|---|
| Malignancy Estimation Using Risk Score | 2.0 |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women With Breast Tumors | — | — | — |
| Age, Categorical(Participants) | Women With Breast Tumors |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 7 |
| Age, Continuous(years) | Women With Breast Tumors |
|---|---|
| Mean | 58.1 ± 14.9 |
| Sex: Female, Male(Participants) | Women With Breast Tumors |
|---|---|
| Female | 20 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Women With Breast Tumors |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Women With Breast Tumors |
|---|---|
| United States | 20 |
No study locations are listed for this record.
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