Cone Beam Computed Tomography for Breast Imaging

NCT01107860 | Completed DMC

• 2 other identifiers: KBCT-0032R44CA103236-05A1
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology

  The primary measure of this study will include the following aspects. * the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam * patient's comfort during the CBCT exam vs the mammographic exam * the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies * the concordance and discordance of CBCT breast imaging with histopathology * number of participants with adverse events as a measure of safety

  about 3 years

Study Arms (2)

Group I

Device: Computed Tomography

Group II

Device: Computed Tomography

Interventions

Computed Tomography DEVICE

In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.

Group I

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from the patient population at a community based clinic, Elizabeth Wende Breast Care, LLC, which is located in Rochester, NY. Group I will consist of subjects who have had mammograms read as BIRADS® 1 or 2. Group II will be subjects who have had a diagnostic mammogram read as BIRADS® 4 or 5 prior to breast biopsy.

You may qualify if:

• Group I:
• Females at least 35 years of age of any ethnicity
• Had a mammogram, read as BI-RADS® 1 or 2
• Will undergo study imaging no later than four weeks from date of mammogram.
• Is able to undergo informed consent.
• Group II:
• Females at least 35 years of age of any ethnicity
• Require diagnostic imaging
• Will undergo study imaging no later than four weeks from date of diagnostic mammogram
• Is able to undergo informed consent

You may not qualify if:

• Group I and Group II:
• Pregnancy
• Lactation
• Subjects 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.
• Subjects who are unable to tolerate study constraints.
• Subjects 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 Hodgkins disease
• Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
• Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
• Tuberculosis
• Severe scoliosis

Sponsors & Collaborators

• Koning Corporation: lead
• Elizabeth Wende Breast Care, LLC: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Posy Seifert, D.O.

  Elizabeth Wende Breast Care, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: April 21, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)