Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method (TRIGUIDE Trial) - A Randomized Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients diagnosed with non-palpable and ecovisible infiltrating breast carcinoma, classified as T1 and T2, eligible for primary breast-conserving surgery (BCS)
Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Eduard Mension, MD PhD
edmension@gmail.com
+34 626207171
Backup
Ines Torras
itorrascaral@gmail.com
+34 699441551
Time Frame
Start Date: 2023-10-04
Estimated Completion Date: 2025-10
Participants
Target number of participants: 150
Treatments
Active_comparator: Wire-guided
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.
Active_comparator: Intraoperative Ultrasound
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.
Active_comparator: Radioactive seed
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona