Koning Breast CT for Breast Imaging in China

Breast Cancer Clinical Trial

Official title:

Koning Breast CT for Breast Imaging in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792999
• Other study ID #: KBCT-CN-001
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2013
• Last updated: March 5, 2018
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2018
• Source: Koning (Tianjin) Medical Equipment Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Koning (Tianjin) Medical Equipment Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of KBCT, CE-KBCT and Mammography	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.	1 year
Secondary	Safety of KBCT, CE-KBCT and Mammography	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.	1 year