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SLNB After Nipple Sparing Mastectomy

A

Acibadem University

Status

Unknown

Conditions

Mastectomy, Subcutaneous
Sentinel Lymph Node Biopsy

Treatments

Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)

Study type

Interventional

Funder types

Other

Identifiers

NCT04140188
RISA-19-01

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: previous axillary dissection and active breast cancer

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Axilla no touch
Active Comparator group
Description:
Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM
Treatment:
Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)
Axilla with previous SLNB
Active Comparator group
Description:
Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM
Treatment:
Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)

Trial contacts and locations

1

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Central trial contact

Halil KARA; Akif Enes Arikan

Data sourced from clinicaltrials.gov

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