SPY
Observational Study to Compare Research-only Breast Ultrasound to Standard of Care Physical Exam for Identifying Tissue Necrosis in Post-mastectomy Patients Undergoing Planned Breast Reconstruction.
Sponsor study identifier
observational
100
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2014
Actual (reported)May 22, 2014
Actual (reported)January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of post-operative fat necrosis
Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.
3-6 months post-operatively
Breast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery.
Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.
University of Washington Medical Center
Seattle, Washington, 98195, United States
First Submitted
May 19, 2014
First Posted
May 22, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)Fat Metabolism Following Chemotherapy in Breast Cancer
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 24, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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