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SLNB After Nipple Sparing Mastectomy

Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04140188
Enrollment
20
Registered
2019-10-25
Start date
2019-11-30
Completion date
2020-06-30
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastectomy, Subcutaneous, Sentinel Lymph Node Biopsy

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.

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.

Interventions

DIAGNOSTIC_TESTSenti-Scint (99mTc- pertechnetate combined with human albumin)

Senti-Scint will be injected via intradermal route to the breast with history of previous NSM.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
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 \-

Design outcomes

Primary

MeasureTime frameDescription
Enhancement in axilla4 hours after injectionHot nodules will be showed in axilla after injection of SENTI-SCINT

Countries

Turkey (Türkiye)

Contacts

Primary ContactHalil KARA
halil.kara@acibadem.edu.tr+905326073933
Backup ContactAkif Enes Arikan
enes.arikan@acibadem.com.tr+905308222345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026