Cone Beam Computed Tomography for Breast Imaging (CBCTBI)

Koning Health

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Radiation: Computed Tomography

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972413

KBCT-001

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

Female

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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