Reader Study for Image Quality of Cone Beam Breast CT System

Breast Neoplasms Clinical Trial

Official title:

Reader Study for Image Quality of Cone Beam Breast CT System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864667
• Other study ID #: 16-02
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 9, 2016
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.

The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.

Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.

Description:

Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.

The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.

Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.

Images from ten (10) female patients (cases) with different breast sizes will be evaluated by 3 independent board-certified, MQSA-qualified radiologists (readers). The images were acquired from a separate clinical trial using KBCT system with the new table/detector.

Two readers will independently evaluate the image quality of each case and choose to "accept" or "reject" the case. If there is a disagreement for a certain case, a third reader will independently evaluate that case and give the final result.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Females at least 35 years of age of any ethnicity

• Had a mammogram, read as BIRADS 1 or 2 (group I) or BIRADS 4 or 5 (group II)

• Will undergo study imaging no later than four weeks from date of mammogram

• Is able to undergo informed consent

• Require diagnostic imaging

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 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 Hodgkin's 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Koning Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejection Rate		One hour training session followed by a one hour reading session	No