Role of 3D Tomography in Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
Role of 3D Tomography in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: computed tomography (CT scan)
* Device: computed tomography (CT scan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All 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 are eligible to participate, except for exclusions noted below. Able to provide informed consent. Exclusion Criteria: 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 Severe scoliosis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I Microcalcifications<br>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)<br>* Subjects will undergo cone beam breast CT scan<br>* Other names: CT scan;|
| Group II Soft tissue findings<br>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)<br>* Subjects will undergo cone beam breast CT scan<br>* Other names: CT scan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, CT scans, mammography