Status:
COMPLETED
Koning Breast CT for Breast Imaging in China
Lead Sponsor:
Koning (Tianjin) Medical Equipment Co., Ltd
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Non-contrast KBCT
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT01792999
Start Date
May 1 2012
End Date
November 1 2014
Last Update
March 7 2018
Active Locations (2)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060