A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential

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General Electric (GE)

Status

Completed

Conditions

Image Correction

Treatments

Radiation: Digital Breast Tomosynthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT01885143
101.01-2013-GES-0001

Details and patient eligibility

About

Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.

Enrollment

80 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ability to provide written informed consent or have a legally authorized representative provide written informed consent
  • Female subjects who are 40 years of age or older
  • Subject has no history of symptoms and/or physical signs of breast cancer on the side of the targeted breast
  • Subject underwent routine Full-Field Digital Mammography (FFDM) which showed one or more abnormalities, including calcifications, and was referred for diagnostic work-up within 4 weeks
  • Subject is surgically sterile (must have documentation of bilateral oophorectomy and/or documented hysterectomy), post-menopausal (must have documentation of cessation of menses for greater than one year) or, if of childbearing potential, a documented negative urine pregnancy test within 4 weeks is required.
  • Subject breast size is compatible with the dimensions of 24x31 cm of the image detector
  • Subject must be in sufficient good health to be able to undergo an examination on mammography equipment as determined by the Investigator

Exclusion criteria

  • Subject or a legally authorized representative is unable to provide written informed consent
  • Clinical assessment and DBT cannot be performed within 4 weeks of screening FFDM examination
  • Subject is breast-feeding
  • Subject has breast implants or reconstructed breasts
  • Subject is undergoing radiotherapy or chemotherapy
  • Subject has a history of prior radiotherapy treatment on the side of the targeted breast
  • Subject has been previously enrolled in this study
  • Subject is participating or has participated in another trial of an investigational product

Trial design

80 participants in 2 patient groups

Artifact Correction
Description:
A minimum of 6 subjects will be recruited for the purpose of evaluating artifact correction
Treatment:
Radiation: Digital Breast Tomosynthesis
Lossy Compression
Description:
A minimum of 6 subjects will be recruited for the purpose of evaluating lossy compression
Treatment:
Radiation: Digital Breast Tomosynthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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