Sienna+® Injection Time Study 4 Arms (Sentimag02)

November 23, 2015 updated by: Nik Hauser, Kantonsspital Baden

Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally:

  • Sienna+® retro-mamillary 1 day before surgery: 10 patients
  • Sienna+® peri-tumorally 1 day before surgery: 10 patients
  • Sienna+® retro-mamillary 4-6 days before surgery: 10 patients
  • Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden
        • Contact:
      • Berne, Switzerland, 3010
        • Inselspital Bern, Universitätsklinik für Frauen.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject has a diagnosis of primary breast cancer
  • Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure
  • Subject is ≥18 years old at time of consent
  • Subject has an ECOG performance status of Grade 0-2
  • Subject has a clinical negative node status
  • Subject is available for the follow-up

Exclusion Criteria:

  • Subject is pregnant or lactating
  • Subject has a radiological evidence of metastatic cancer
  • Subject has had previous axilla surgery or reduction mammoplasty
  • Subject has impaired lymphatic function
  • Subject has had a preoperative radiation therapy
  • Subject has iron overload disease or iron/dextran intolerance
  • Subject has a pacemaker
  • Subject is under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sienna+ retro and Technetium 1

Sienna+® is administered retro-mamillary 1 day before surgery for sentinel node marking.

Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
Device: Sienna+ retro
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
Device: Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Active Comparator: Sienna+ peri and Technetium 1

Sienna+® is administered peri-tumorally 1 day before surgery for sentinel node marking.

Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
Device: Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Device: Sienna+ peri
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
Active Comparator: Sienna+ retro 4-6 and Technetium 1

Sienna+® is administered retro-mamillary 4-6 days before surgery for sentinel node marking.

Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
Device: Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Device: Sienna+ retro 4-6
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
Active Comparator: Sienna+ peri 4-6 and Technetium 1

Sienna+® is administered peri-tumorally 4-6 days before surgery for sentinel node marking.

Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.
Device: Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Device: Sienna+ peri 4-6
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate per Patient
Time Frame: During surgery
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lymph nodes excised
Time Frame: During surgery
Number of excised sentinel lymph nodes
During surgery
Nodal detection rate
Time Frame: During surgery
Number of detected versus excised sentinel lymph nodes with either method.
During surgery
Malignancy rate
Time Frame: 1-2 days post surgery
Number of histologically confirmed malignant sentinel lymph nodes detected with either method.
1-2 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Baden

Collaborators

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Nik Hauser, PD Dr., Kantonsspital Baden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baden201512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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