Koning Breast CT for Breast Imaging in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-11-30

Brief Summary

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This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Non-contrast KBCT

About 187 subjects, who had diagnostic imaging of the breast including mammography and were categorized as Breast Imaging-Reporting and Data System(BIRADS) scores 1, 2, 3, 4, or 5, received KBCT imaging without contrast injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Contrast-enhanced KBCT

About 231 subjects, who had diagnostic imaging of the breast including mammography and were scheduled for biopsy or surgery, received contrast-enhanced KBCT imaging of the affected breast before biopsy or surgery.

Group Type EXPERIMENTAL

Contrast-enhanced KBCT

Intervention Type DEVICE

Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired.

Interventions

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Contrast-enhanced KBCT

Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females at least 35 years of age of any ethnicity
* Had diagnostic imaging
* Will undergo study imaging no later than two weeks from date of diagnostic mammogram
* Is able to undergo informed consent

* Females at least 35 years of age of any ethnicity
* Had diagnostic imaging and was determined to have biopsy or surgery
* Will undergo study imaging no later than two weeks from date of diagnostic mammogram
* Is able to undergo informed consent

Exclusion Criteria

* 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

Contrast-enhanced KBCT

* Abnormal Glomerular Filtration Rate (GFR)/Blood Urea Nitrogen (BUN) or Creatinine at Pre contrast blood screening
* Previous non-ionic contrast reaction
* History of renal dysfunction/kidney disease
* Diabetes mellitus treated with metformin
* Multiple myeloma
* Dehydration
* History of nephrotoxic medication use
* Hyperthyroidism
* Pheochromocytoma
* Sickle Cell Disease

Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes