Clinical trial NCT00763100: Efficacy of Tomosynthesis in the BIRADS 3 Population
Official title: The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Three dimensional versus two dimensional
Breast cancer surveillance
Tomosynthesis
Lead sponsor: WellSpan Health
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2008-09-30
Enrollment: 690
Sex: FEMALE
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of patients will be enrolled:

Group 1 will enroll patients that have been categorized as a BIRADS 3 on the basis of screening and diagnostic conventional imaging work-up.

Group II will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they have undergone breast conservation therapy for breast cancer.

Group III will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they are currently undergoing primary systemic therapy.

Brief summary: There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

GROUP 1

* female of any race and ethnicity
* 35 years or older
* after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
* subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
* female of any race and ethnicity
* 26 years or older
* subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
* subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
* female of any race and ethnicity
* 26 years or older
* subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
* subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

* GROUP 1, 2 and 3
* subjects unable or unwilling to participate
* subjects who are unable or unwilling to tolerate compression
* subjects who are pregnant or who think they may be pregnant
* subjects who are breastfeeding

Primary outcomes:
measure: to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: WellSpan Health
name: Joanne Trapeni, DO
role: PRINCIPAL_INVESTIGATOR
References: