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Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method

NCT06186011 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-29

No results posted yet for this study

Summary

The goal of this clinical trial is to compare Quality of Life and cosmetic outcomes in Breast Conservative Carcer surgery depending on localization method (intraoperative Ultrasound, wire and radioactive seed).

Participants will be randomly assigned to one of the three proposed arms, and the primary surgery will be performed.

Conditions

Interventions

PROCEDURE

Wire-guided surgery

If assigned to the WGS, the marking will be performed by the radiologist on the day prior to the intervention.

PROCEDURE

Radioactive seed localization

If assigned to the RSL, the marking will be performed by the radiologist on the day prior to the intervention. The handling and traceability will be done by the nuclear medicine physician.

PROCEDURE

Intraoperative ultrasound localization

If the patient is assigned to the Intraoperative ultrasound localization (IOUS), no further procedures will be necessary until surgery. Subsenquently, the primary surgery will be performed.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Eduard Mension, MD PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT06186011 on ClinicalTrials.gov