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CompletedNCT00763100BIRADSUpdated Jan 6, 2011

Efficacy of Tomosynthesis in the BIRADS 3 Population

An observational study in Breast Cancer, sponsored by WellSpan Health. Completed. Open to female participants aged 26 Years and older. Per ClinicalTrials.gov, last updated 2011-01-06.

Sponsored by WellSpan Health · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
690
Ages
26 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • Three dimensional versus two dimensional
  • Breast cancer surveillance
  • Tomosynthesis
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 690 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

WellSpan Health is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
26 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
690 participants (estimated)

Groups and cohorts

  • Breast cancer

    Patients in treatment or post-treatment for breast cancer

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What researchers measure

Primary outcomes

  1. to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).

    Time frame: 5 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00763100
Lead sponsor
WellSpan Health
Collaborators
Hologic, Inc.
First posted
Sep 30, 2008
Start date
May 2008
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Jan 6, 2011

Study contacts

Joanne Trapeni, DO
principal investigator · WellSpan Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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