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Completed

NCT Number: NCT03196635

Patient-Assisted Compression - Impact on Image Quality and Workflow

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, 33486, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient-Assisted (PA) Breast Compression

Device

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

Device

TC compression will be conducted per standard of care practices at the site.

Primary outcomes

  1. Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets

    Time frame: Through study completion, on average 1 month

    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.

Secondary outcomes

  1. Repeat Image Acquisition

    Time frame: Through study completion, on average 1 month

    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.

  2. Acceptability of Mammographic Attributes

    Time frame: Through study completion, on average 1 month

    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.

Other outcomes

  1. Comparison of Image Acquisition Time

    Time frame: Through study completion, on average 1 month

    The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.

  2. Technologist Interventions in PA Compression

    Time frame: Through study completion, on average 1 month

    Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.

  3. Compression Force for PA and TC Compressions

    Time frame: Through study completion, on average 1 month

    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.

  4. Breast Thickness for PA and TC Compressions

    Time frame: Through study completion, on average 1 month

    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.

  5. Radiation Dose for PA and TC Compressions

    Time frame: Through study completion, on average 1 month

    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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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