NCT04140188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 24, 2019

Last Update Submit

October 26, 2019

Conditions

Sentinel Lymph Node BiopsyMastectomy, Subcutaneous

Outcome Measures

Primary Outcomes (1)

  • Enhancement in axilla

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

    4 hours after injection

Study Arms (2)

Axilla no touch

ACTIVE COMPARATOR

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)

Axilla with previous SLNB

ACTIVE COMPARATOR

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)

Interventions

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

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

Axilla no touchAxilla with previous SLNB

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer is rarely seen in male patients and NSM is not performed thus study group consist of female volunteers.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 17262724BACKGROUND

  • 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.

    PMID: 18926457BACKGROUND

Study Officials

  • Halil KARA

    Acibadem University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Halil KARA

CONTACT

+905326073933halil.kara@acibadem.edu.tr

Akif Enes Arikan

CONTACT

+905308222345enes.arikan@acibadem.com.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 25, 2019

Study Start

November 1, 2019

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

TU(1)