Koning Breast CT for Breast Imaging in China

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Device: Contrast-enhanced KBCT

• Registration Number: NCT01792999
• Lead Sponsor: Koning (Tianjin) Medical Equipment Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 418

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contrast-enhanced KBCT	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of KBCT, CE-KBCT and Mammography	1 year	Efficacy of KBCT, CE-KBCT and Mammography will be assessed based on the sensitivity for detecting breast cancer and the specificity for correctly categorizing non-cancer.

Secondary Outcome Measures

Name	Time	Method
Safety of KBCT, CE-KBCT and Mammography	1 year	All enrolled and scanned patients will be included in the safety analysis. Anticipated and unanticipated adverse events will be tabulated according to severity and relation to device.

Trial Locations

Locations (2)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China