Targeted Axillary Dissection for Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre hospitalier de l'Université de Montréal, Montreal, CanadaMetastasis+4 MoreTargeted Axillary Dissection - Procedure
Eligibility
18+
Female
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Study Summary

This trial is testing a new method for axillary staging in breast cancer patients with 1-2 positive sentinel nodes. The new method uses radioactive seed localization (RSL) to guide removal of the biopsy-proven node (TAD). The study will compare the technical success rate and accuracy of SNB+RSL to standard SNB.

Eligible Conditions
  • Lymph Node Metastasis
  • Breast Cancer
  • Axillary Metastases
  • Sentinel Lymph Node

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1 month

1 month
False negative rate (FNR) of Radioactive Seed Localisation (RSL)
False negative rate (FNR) of Sentinel Node Biopsy (SNB)
False negative rate (FNR) of Targeted Axillary Dissection (TAD)
Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
Technical failure rate (TFR) of Radioactive Seed Localisation (RSL)
Technical failure rate (TFR) of Sentinel Node Biopsy (SNB)
Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)

Trial Safety

Trial Design

1 Treatment Group

Targeted Axillary Dissection
1 of 1

Experimental Treatment

98 Total Participants · 1 Treatment Group

Primary Treatment: Targeted Axillary Dissection · No Placebo Group · N/A

Targeted Axillary DissectionExperimental Group · 2 Interventions: Targeted Axillary Dissection, Ultrasound of the axilla · Intervention Types: Procedure, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month

Who is running the clinical trial?

Jewish General HospitalLead Sponsor
135 Previous Clinical Trials
319,550 Total Patients Enrolled
Quebec Breast Cancer FoundationOTHER
4 Previous Clinical Trials
698 Total Patients Enrolled
Erica Patocskai, MDStudy DirectorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
182 Total Patients Enrolled
Jean-François Boileau, MD,MSc,FRCSCStudy ChairJewish General Hospital
Léamarie Meloche-Dumas, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

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References

Frequently Asked Questions

How many individuals are participating in the trial overall?

"Correct. Per the information available on clinicaltrials.gov, recruitment is in progress for this trial which was first posted on March 30th 2021 and last amended May 19th 2021. The goal is to bring 98 patients into the study at 2 sites." - Anonymous Online Contributor

Unverified Answer

Are there any current openings to join this research project?

"According to the clinicaltrials.gov database, this medical research project is currently seeking participants. It was first announced on March 30th 2021 and has undergone a recent revision of May 19th this year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.