Cryotherapy in Breast B3 Lesions

Not Applicable

• Conditions: Breast Disease; Phyllodes Breast Tumor

• Registration Number: NCT04571307
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

To determine the feasibility of cryotherapy for B3 fibroepithelial lesions

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-05
• Study Start: 2021-09-15
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• lesion seen on ultrasound
• core biopsy revealed FEL of B3
• lesion </+3.5cm
• keen for cryotherapy instead of surgery
• has other breast lesions for followup

Exclusion Criteria

• cancer patients
• patients with bleeding diathesis
• lesions causing visible breast deformity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
breast cosmetic outcome	at 1 year post procedure	patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
recurrence of the lesion	2 years from procedure	assessed on ultrasound
pain score	at 2 weeks post procedure	using pain score scale of 0-10, a higher score indicates a worse outcome

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore