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

NCT06186011 | Unknown

• 1 other identifier: HCB/2023/0141
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Quality of Life; Cosmetic outcomes

Outcome Measures

Primary Outcomes (2)

• BCCT.core

  BCCT.core is a semi-automatic software validated for the assessment of cosmetic outcomes following BCS. It provides an objective measure and has been demonstrated to correlate well to a panel of experts. BCCT.core analyses several parameters including symmetry, skin colour and scar visibility to evaluate breast cosmesis, and classifies the overall cosmetic result into four classes: Excellent, Good, Fair and Poor. However, BCCT.core does not incorporate patient self-perception of outcome and does not directly assess the volume of breast excised. Standardized clinical photographs were taken 1-year post-surgery with or without radiotherapy, as recommended by the BCCT.core software developers and assessed at the end of the data collection period by a single investigator, blinded to the identification and treatment group of the participant.

  12 months after surgery

• BREAST-Q questionnaire

  The BREAST-Q questionnaire is a specific and validated Patient-Reported Outcome Measure (PROM) for patients undergoing breast surgery designed to assess the outcomes and satisfaction of individuals, which measures health-related QoL (physical well-being, psychological and sexual) and satisfaction (satisfaction with the breast, satisfaction with the overall result and satisfaction with the care received). Each scale is scored to generate a numeric score on a scale from 0 (worst) to 100 (best). These measures were studied at baseline (preoperative) and 12 months post-surgery.

  preoperative, 12 months after surgery

Secondary Outcomes (7)

• Excess volume resection

  Inmediatly after surgery

• Margin status

  Inmediatly after surgery

• Ampliations

  Inmediatly after surgery

• Additional treatment interventions

  3 weeks and 12 months after surgery

• Excision time

  Inmediatly after surgery

Study Arms (3)

Wire-guided

ACTIVE COMPARATOR

Wire guided localization (WGL) is considered the standard method for intraoperative localization of non-palpable breast lesions, chosen by many centers worldwide. It involves the placement of a wire or barbed needle that is percutaneously introduced into the lesion using a guide. It is cost-effective, easy to place guided by ultrasound or stereotaxis, allows for repositioning in case of error, and its safety and efficacy have been widely demonstrated in the literature.

Procedure: Wire-guided surgery

Intraoperative Ultrasound

ACTIVE COMPARATOR

The use of intraoperative ultrasound (IOUS) is an effective method that is controlled by the surgeon and does not require the involvement of other departments or preoperative invasive procedures. IOUS has been introduced into clinical practice as a tool for visualizing non-palpable tumors, demonstrating the detection of nearly 100% of lesions, and a rate of negative margins and re-excision similar to WGL. One of the challenges of the technique in ultrasound-guided surgery arises when the tumor is \<5mm, making it difficult to visualize by ultrasound, or when there are microcalcifications not visible by ultrasound.

Procedure: Intraoperative ultrasound localization

Radioactive seed

ACTIVE COMPARATOR

Radioactive seeds are composed of a titanium capsule with an I-125 filament inside. They have low radioactivity, which can range from 7 to 200 μCi. During surgery, the seeds are detected using a portable gamma ray detection probe typically used for sentinel lymph node biopsy, configured to detect an I-125 source (27 keV). This probe has a wide detection range through tissue (\>10 cm), currently offering the greatest detection range compared to other available localization devices. Radioactive seed localization (RSL) require coordination between the radiology and nuclear medicine departments for marking. The results in terms of lesion localization and margin involvement rates are comparable to WGL.

Procedure: Radioactive seed localization

Interventions

Wire-guided surgery PROCEDURE

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

Wire-guided

Radioactive seed localization PROCEDURE

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.

Radioactive seed

Intraoperative ultrasound localization PROCEDURE

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.

Intraoperative Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with non-palpable and ecovisible infiltrating breast carcinoma, classified as T1 and T2, eligible for primary breast-conserving surgery (BCS)

You may not qualify if:

• lesions \<5mm
• multicentric tumors
• extensive calcifications not visible by ultrasound
• level III oncoplastic techniques or mastectomy

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eduard Mension, MD PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduard Mension, MD PhD

CONTACT

+34 626207171; edmension@gmail.com

Ines Torras

CONTACT

+34 699441551; itorrascaral@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center parallel randomized Clinical Trial with three arms: intraoperative Ultrasound vs. wire vs. radioactive seed

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: October 4, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-10

Locations

ES (1)