Koning Breast CT for Breast Imaging in China

Koning Health

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Device: Contrast-enhanced KBCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01792999

KBCT-CN-001

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Non-contrast KBCT

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

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

Inclusion Criteria:

• 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:

Same as the exclusion criteria as non-contrast KBCT, plus the following:

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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418 participants in 2 patient groups

Non-contrast KBCT

No Intervention group

Description:

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.

Contrast-enhanced KBCT

Experimental group

Description:

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.

Treatment:

Device: Contrast-enhanced KBCT