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Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

NCT01664091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-08-26

Study results available
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Summary

This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).

Conditions

Interventions

RADIATION

post-mastectomy radiation therapy (PMRT)

DEVICE

tissue expander (TE)

DEVICE

acellular dermal matrix (ADM)

Sponsors & Collaborators

Principal Investigators

  • Julia Wong, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664091 on ClinicalTrials.gov