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Sienna+® Injection Time Study 4 Arms

NCT02612870 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-11-24

No results posted yet for this study

Summary

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

Sienna+ retro

Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery

DEVICE

Sienna+ peri

Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery

DEVICE

Sienna+ retro 4-6

Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery

DEVICE

Sienna+ peri 4-6

Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery

DEVICE

Technetium 1

Sentinel node marking with Technetium 1 day before surgery

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Kantonsspital Baden

    lead OTHER

Principal Investigators

  • Nik Hauser, PD Dr. · Kantonsspital Baden

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612870 on ClinicalTrials.gov