Clinical Trials Logo
  1. Home
  2. Sentinel Lymph Node Biopsy
  3. NCT04140188
  4. Details
NCT04140188 Clinical Trial

SLNB After Nipple Sparing Mastectomy

Sentinel Lymph Node Biopsy Clinical Trial

Official title:
Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04140188
Other study ID # RISA-19-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2019
Est. completion date June 2020

Study information
Verified date October 2019
Source Acibadem University
Contact Halil KARA
Phone +905326073933
Email halil.kara@acibadem.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: NSM with/without SLNB at least 6 months prior to this study -

Exclusion Criteria: previous axillary dissection and active breast cancer

-

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Acibadem Maslak Hospital Istanbul Sariyer

Sponsors (1)
Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Enhancement in axilla Hot nodules will be showed in axilla after injection of SENTI-SCINT 4 hours after injection
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03719833 - Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
Recruiting NCT00654342 - Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer N/A
Recruiting NCT01564264 - Sentinel Node Biopsy in Endometrial Cancer N/A
Recruiting NCT06212440 - Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy N/A
Terminated NCT03630653 - Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse N/A
Completed NCT03833960 - SLNB After Neoadjuvant Treatment in Node Positive Patients
Active, not recruiting NCT04986306 - The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients
Recruiting NCT05512468 - Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy N/A
Recruiting NCT03199560 - Tilmanocept vs Sulfur Colloid in Sentinel Lymph Node Biopsy Phase 4
Not yet recruiting NCT04932460 - Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy N/A
Recruiting NCT03680833 - Sentinel Node Detection in Cervical Cancer N/A
Completed NCT03200704 - A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer Phase 3
Recruiting NCT04403867 - The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
Not yet recruiting NCT05703295 - Oncologic Safety of Sentinel Lymph Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients
Enrolling by invitation NCT05942170 - The Combination of Preoperative MRI and SLN in the Surgical Management of CC and EC N/A
Recruiting NCT03937414 - Intraoperative Molecular Diagnosis of Sentinel Lymph Node In Breast Cancer Patients N/A
Recruiting NCT06120439 - Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy N/A
Terminated NCT05457842 - A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery Phase 2