SLNB After Nipple Sparing Mastectomy

• Sponsor: Acibadem University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04140188
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.

Condition or Disease	Intervention/Treatment	Phase
Sentinel Lymph Node Biopsy; Mastectomy, Subcutaneous	Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)	N/A

Detailed Description

Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study
• Anticipated Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Axilla no touch Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM	Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin); Senti-Scint will be injected via intradermal route to the breast with history of previous NSM.
Active Comparator: Axilla with previous SLNB Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM	Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin); Senti-Scint will be injected via intradermal route to the breast with history of previous NSM.

Outcome Measures

Primary Outcome Measures

1. Enhancement in axilla [4 hours after injection]

   Hot nodules will be showed in axilla after injection of SENTI-SCINT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria: NSM with/without SLNB at least 6 months prior to this study -

Exclusion Criteria: previous axillary dissection and active breast cancer

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Maslak Hospital	Istanbul	Sariyer	Turkey	34457

Sponsors and Collaborators

• Acibadem University

Investigators

• Principal Investigator: Halil KARA, Acibadem University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Intra M, Veronesi P, Gentilini OD, Trifirò G, Berrettini A, Cecilio R, Colleoni M, Rietjens M, Luini A, Paganelli G, Veronesi U. Sentinel lymph node biopsy is feasible even after total mastectomy. J Surg Oncol. 2007 Feb 1;95(2):175-9.
• Karam A, Stempel M, Cody HS 3rd, Port ER. Reoperative sentinel lymph node biopsy after previous mastectomy. J Am Coll Surg. 2008 Oct;207(4):543-8. doi: 10.1016/j.jamcollsurg.2008.06.139. Epub 2008 Jul 21.

• Responsible Party: Halil KARA, Principal Investigator, Acibadem University
• ClinicalTrials.gov Identifier: NCT04140188
• Other Study ID Numbers: RISA-19-01
• First Posted: Oct 25, 2019
• Last Update Posted: Oct 29, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sodium Pertechnetate Tc 99m

Study Results

No Results Posted as of Oct 29, 2019