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Sienna+® Injection Time Study 4 Arms (Sentimag02)

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ClinicalTrials.gov Identifier: NCT02612870
Recruitment Status : Unknown
Verified November 2015 by Nik Hauser, Kantonsspital Baden.
Recruitment status was:  Not yet recruiting
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Nik Hauser, Kantonsspital Baden

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: Sienna+ retro Device: Sienna+ peri Device: Sienna+ retro 4-6 Device: Sienna+ peri 4-6 Device: Technetium 1 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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

Device: Technetium 1
Sentinel node marking with Technetium 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: Sienna+ retro 4-6
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery

Device: Technetium 1
Sentinel node marking with Technetium 1 day 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: 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




Primary Outcome Measures :
  1. Detection rate per Patient [ Time Frame: During surgery ]
    Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.


Secondary Outcome Measures :
  1. Number of lymph nodes excised [ Time Frame: During surgery ]
    Number of excised sentinel lymph nodes

  2. Nodal detection rate [ Time Frame: During surgery ]
    Number of detected versus excised sentinel lymph nodes with either method.

  3. Malignancy rate [ Time Frame: 1-2 days post surgery ]
    Number of histologically confirmed malignant sentinel lymph nodes detected with either method.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612870


Contacts
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Contact: Nik Hauser, PD Dr. +41 56 486 36 36 brustzentrum@ksb.ch
Contact: Cornelia Leo, PD Dr. med. +41 56 486 36 36 brustzentrum@ksb.ch

Locations
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Switzerland
Kantonsspital Baden Not yet recruiting
Baden, Switzerland, 5404
Contact: Nik Hauser, PD Dr.    +41 56 486 36 36    brustzentrum@ksb.ch   
Inselspital Bern, Universitätsklinik für Frauen. Not yet recruiting
Berne, Switzerland, 3010
Contact: Patrizia Sager, Dr. med.    +41 31 632 18 40    patrizia.sager@insel.ch   
Sponsors and Collaborators
Kantonsspital Baden
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Nik Hauser, PD Dr. Kantonsspital Baden

Publications of Results:
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Responsible Party: Nik Hauser, Director Department of Gynecology and Obstetrics, Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT02612870     History of Changes
Other Study ID Numbers: Baden201512
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by Nik Hauser, Kantonsspital Baden:
Breast Cancer
Sentinel Node
Sentinel Node Biopsy
Breast Surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases