Clinical trial NCT01792999: Koning Breast CT for Breast Imaging in China
Official title: Koning Breast CT for Breast Imaging in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast CT
Lead sponsor: Koning (Tianjin) Medical Equipment Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 418
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Efficacy of KBCT, CE-KBCT and Mammography
timeFrame: 1 year
Secondary outcomes:
measure: Safety of KBCT, CE-KBCT and Mammography
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhaoxiang Ye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Peihong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: