Cone Beam CT for Breast Imaging

NCT01880580 | Completed DMC

• 1 other identifier: URMC-001
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Imaging; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Image Quality of Cone Beam Breast CT

  This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.

  6 years

Study Arms (2)

Normal Group

In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information.

Diagnostic Group

The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Group II includes forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Koning Corporation: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Highland Breast Imaging Center

Rochester, New York, 14620, United States

Location

Related Publications (2)

• O'Connell A, Conover DL, Zhang Y, Seifert P, Logan-Young W, Lin CF, Sahler L, Ning R. Cone-beam CT for breast imaging: Radiation dose, breast coverage, and image quality. AJR Am J Roentgenol. 2010 Aug;195(2):496-509. doi: 10.2214/AJR.08.1017.

  PMID: 20651210 RESULT

• O'Connell AM, Kawakyu-O'Connor D. Dedicated Cone-beam Breast Computed Tomography and Diagnostic Mammography: Comparison of Radiation Dose, Patient Comfort, And Qualitative Review of Imaging Findings in BI-RADS 4 and 5 Lesions. J Clin Imaging Sci. 2012;2:7. doi: 10.4103/2156-7514.93274. Epub 2012 Feb 25.

  PMID: 22439131 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 15, 2013
• First Posted: June 19, 2013
• Study Start: July 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)