Role of 3D Tomography in Breast Cancer

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University of Rochester

Status

Completed

Conditions

Breast Cancer

Treatments

Device: computed tomography (CT scan)

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01090687
URMC-UMASS
1R21CA134128-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.

Enrollment

150 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
  • Able to provide informed consent.

Exclusion criteria

  • Males
  • Women less than 40 years old
  • Pregnant women
  • Lactating women
  • Woman who have had bilateral mastectomies
  • Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
  • Women who are unable to tolerate study constraints, frail or unable to cooperate
  • Women with large breasts that cannot be accommodated within the field of view of the CT system

Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  • Treatment for enlarged thymus gland as an infant
  • Irradiation for benign breast conditions, including breast inflammation after giving birth
  • Treatment for Hodgkin's disease
  • Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  • Tuberculosis
  • Severe scoliosis

Trial design

150 participants in 2 patient groups

Group I Microcalcifications
Description:
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan.
Group II Soft tissue findings
Description:
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan.
Treatment:
Device: computed tomography (CT scan)
Device: computed tomography (CT scan)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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