Cone Beam CT for Breast Imaging

Cone Beam CT for Breast Imaging: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01880580

Enrollment

Registered

2013-06-19

Start date

2006-07-31

Completion date

2012-06-30

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Imaging

Brief summary

The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Normal Group: Inclusion Criteria: * Are at least 40 years of age of any ethnicity * Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3 * Will undergo study imaging no later than six months from date of routine mammogram. * Is able to undergo informed consent.

Exclusion criteria

* Pregnancy * Lactation * Patients 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. * Patients who are unable to tolerate study constraints. * Patients 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 * Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * Tuberculosis * Severe scoliosis Diagnostic Group: Inclusion Criteria: * Women who are at least 40 years of age of any ethnicity * Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality * After diagnostic work-up are categorized as BI-RADS® 4 or 5. * Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy. * Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.

Design outcomes

Primary

Measure	Time frame	Description
Image Quality of Cone Beam Breast CT	6 years	This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.

Countries

United States

Outcome results