Cone Beam Computed Tomography for Breast Imaging

NCT00972413 | Completed Phase 1 DMC

• 1 other identifier: KBCT-001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced 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

Keywords

breast cancer; cone beam computed tomography

Outcome Measures

Primary Outcomes (1)

• The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.

  3 years

Study Arms (3)

Group I

EXPERIMENTAL

Radiation: Computed Tomography

Group II

EXPERIMENTAL

Radiation: Computed Tomography

Group III

EXPERIMENTAL

Radiation: Computed Tomography

Interventions

Computed Tomography RADIATION

In Group I, twelve 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: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group I:
• Are at least 40 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:
• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 4 or 5
• Are scheduled for breast biopsy
• Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
• Is able to undergo informed consent.
• Group III:
• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 4 or 5
• Are scheduled for breast biopsy

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
• Group III:
• Pregnancy

Sponsors & Collaborators

• Koning Corporation: lead

Study Sites (1)

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Posy Seifert, D.O.

  Elizabeth Wende Breast Care, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 7, 2009
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)