Cone Beam CT for Breast Imaging

NCT ID: NCT01880580

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

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:

• Pregnancy
• Lactation
• Patients who have already undergone biopsy for the index lesion
• Patients who are unable or unwilling to undergo biopsy for the lesion of concern
• Patients with physical limitations that may prohibit the patient from 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 or breast area 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Koning Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Rochester Highland Breast Imaging Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20651210 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22439131 (View on PubMed)

Other Identifiers

URMC-001

Identifier Type: -

Identifier Source: org_study_id