NCT01090687

Brief Summary

The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

2.7 years

First QC Date

February 22, 2010

Last Update Submit

July 31, 2013

Conditions

Breast Cancer

Keywords

breast cancer, CT scans, mammography

Outcome Measures

Primary Outcomes (1)

  • Correlation between mammography and breast CT on lesion detection

    There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.

    2 years

Study Arms (2)

Group I Microcalcifications

After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan.

Radiation: computed tomography (CT scan)

Group II Soft tissue findings

After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan.

Device: computed tomography (CT scan)

Interventions

computed tomography (CT scan)RADIATION

Subjects will undergo cone beam breast CT scan

Also known as: CT scan
Group I Microcalcifications

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam, and who meet the inclusion criteria, are eligible to participate.

You may qualify if:

  • Able to provide informed consent.

You may not qualify if:

  • Males
  • Women less than 40 years old
  • Pregnant women
  • Lactating women
  • Woman who have had bilateral mastectomies
  • Women 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
  • Women who are unable to tolerate study constraints, frail or unable to cooperate
  • Women with large breasts that cannot be accommodated within the field of view of the CT system
  • Women 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
  • Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
  • Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
  • Tuberculosis
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center, Highland Breast Imaging Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Andrew Karellas, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

  • Stephen Glick, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

March 22, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations

US(1)