Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

• ClinicalTrials.gov Identifier: NCT05912569
• Recruitment Status: Recruiting
• First Posted: June 22, 2023
• Last Update Posted: April 5, 2024
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Hyeong-Gon Moon, Seoul National University Hospital

Tracking Information

• First Submitted Date: June 12, 2023
• First Posted Date: June 22, 2023
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: June 13, 2023
• Estimated Primary Completion Date: April 28, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 12, 2023)

success rate [ Time Frame: 2 weeks later ]

The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
• Official Title: Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ

Brief Summary

In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.

primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

Detailed Description

Primary surgery:

Patients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included.

Prior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice.

Breast-conserving surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures.

The number of marked sentinel lymph nodes is recorded for documentation.

Confirmation of pathological examination results:

If the final surgical specimen confirms invasive carcinoma (size > 1mm) through pathological examination, sentinel lymph node surgery is performed.

Secondary surgery:

Prior to the surgery, an axillary view x-ray is taken to verify the location and number of the clips.

Blue dye and/or radioisotope injection is administered near the axillary incision site.

Accessing the axillary region, the marked areas using clips or sutures and the detection methods of blue dye/radioisotope are used to identify the sentinel lymph node for sentinel lymph node biopsy.

The number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: DCIS

Intervention

Procedure: Delay sentinel node biopsy

In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I

Study Arms

Experimental: Delay sentinel node biopsy

sinlge arm

Intervention: Procedure: Delay sentinel node biopsy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 12, 2023): 84
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 28, 2025
• Estimated Primary Completion Date: April 28, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients aged 20 to 75 years old.
• Patients diagnosed with DCIS through histological examination.
• Patients undergoing mastectomy

Exclusion Criteria:

• In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
• In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
• In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
• Pregnant patients.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05912569
• Other Study ID Numbers: 2212-088-1386
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Hyeong-Gon Moon, Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Seoul National University Hospital
• Verification Date: April 2024