Cone Beam Computed Tomography for Breast Imaging

Breast Cancer Clinical Trial

— CBCTBI  

Official title:

Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972413
• Other study ID #: KBCT-001
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: December 13, 2012
• Start date: June 2008
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

• Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.

• Is able to undergo informed consent.

Exclusion Criteria:

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

• 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

• Allergy or previous reaction to iodinated contrast material

• History of renal dysfunction/kidney disease

• Long standing diabetes mellitus

• Multiple myeloma

• Dehydration

• History of nephrotoxic medication use

• Hyperthyroidism

• Diabetic patients on Metformin

• Pheochromocytoma

• Sickle Cell Disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Computed Tomography
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.
• Computed Tomography
In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
• Computed Tomography
In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.

Locations

Country	Name	City	State
United States	Elizabeth Wende Breast Care	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Koning Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes