Cone Beam Computed Tomography for Breast Imaging

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Computed Tomography

• Registration Number: NCT00972413
• Lead Sponsor: Koning Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-07
• Primary Completion: 2010-01
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I	Computed Tomography	-
Group II	Computed Tomography	-
Group III	Computed Tomography	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Elizabeth Wende Breast Care; 🇺🇸 Rochester, New York, United States