Patient-Assisted Compression - Impact on Image Quality and Workflow

Breast Cancer Clinical Trial

Official title:

Patient-Assisted Compression - Impact on Image Quality and Workflow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196635
• Other study ID #: 124.03-2017-GES-0002
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: June 29, 2017

Study information

• Verified date: August 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled [TC]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.

Description:

Patient-assisted (PA) compression allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes. This study is being conducted to compare the image quality of breast images obtained using TC compression and PA compression, and to evaluate the impact of PA compression on clinical workflow. The study population will consist of adult asymptomatic women presenting for screening 2D mammography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Are women aged 40 years or older;

• Are asymptomatic and scheduled for FFDM screening mammography;

• Have left and right breasts;

• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;

• Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;

• Are able and willing to comply with study procedures; and

• Are able and willing to provide written informed consent to participate.

Exclusion Criteria:

• Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;

• Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (= 5 years) of the study exam date;

• Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;

• Are currently lactating; or

• Have breast implants.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Patient-Assisted (PA) Breast Compression
The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.
• Technologist-Controlled (TC) Breast Compression
TC compression will be conducted per standard of care practices at the site.

Locations

Country	Name	City	State
United States	Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Image Acquisition Time	The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.	Through study completion, on average 1 month
Other	Technologist Interventions in PA Compression	Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.	Through study completion, on average 1 month
Other	Compression Force for PA and TC Compressions	Compression forces (decanewton [daN]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month
Other	Breast Thickness for PA and TC Compressions	Breast thickness (millimeter [mm]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month
Other	Radiation Dose for PA and TC Compressions	Radiation dose (entrance skin air kerma [ESAK] in milligray [mGy]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month
Primary	Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets	One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.	Through study completion, on average 1 month
Secondary	Repeat Image Acquisition	Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.	Through study completion, on average 1 month
Secondary	Acceptability of Mammographic Attributes	Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.	Through study completion, on average 1 month