PMA Required Pivotal Multi-reader Multi-case Reader Study

NCT01952717 | Completed DMC

• 1 other identifier: KBCT-006
• Study Type: observational
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).

Conditions

Breast Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• Area under the Receiver Operating Characteristics Curve (AUC)

  The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared.

  one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases.

You may qualify if:

• \- At least 40 or 35 years of age of any ethnicity Had a routine mammogram, read as BI-RADS® 3 Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality After diagnostic work-up are categorized as BI-RADS® 4 or 5. Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
• Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up Is able to provide informed consent

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Koning Corporation: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 30, 2013
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03