SLNB After Nipple Sparing Mastectomy

NCT ID: NCT04140188

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Sentinel Lymph Node Biopsy Mastectomy, Subcutaneous

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axilla no touch

Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

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

Axilla with previous SLNB

Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Halil KARA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil KARA

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

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Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Halil KARA

Role: CONTACT

+905326073933

Akif Enes Arikan

Role: CONTACT

+905308222345

Facility Contacts

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Halil KARA

Role: primary

5326073933

Akif Enes Arikan

Role: backup

+905308222345

References

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Intra M, Veronesi P, Gentilini OD, Trifiro 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. doi: 10.1002/jso.20670.

Reference Type BACKGROUND
PMID: 17262724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18926457 (View on PubMed)

Other Identifiers

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RISA-19-01

Identifier Type: -

Identifier Source: org_study_id

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