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Sienna+® Injection Time Study 4 Arms (Sentimag02)

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sienna+ retro
Sienna+ peri
Sienna+ retro 4-6
Sienna+ peri 4-6
Technetium 1
Sponsored by
Kantonsspital Baden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms focused on measuring Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Baden
  • Inselspital Bern, Universitätsklinik für Frauen.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sienna+ retro and Technetium 1

Sienna+ peri and Technetium 1

Sienna+ retro 4-6 and Technetium 1

Sienna+ peri 4-6 and Technetium 1

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Detection rate per Patient
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.

Secondary Outcome Measures

Number of lymph nodes excised
Number of excised sentinel lymph nodes
Nodal detection rate
Number of detected versus excised sentinel lymph nodes with either method.
Malignancy rate
Number of histologically confirmed malignant sentinel lymph nodes detected with either method.

Full Information

First Posted
November 18, 2015
Last Updated
November 23, 2015
Sponsor
Kantonsspital Baden
Collaborators
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02612870
Brief Title
Sienna+® Injection Time Study 4 Arms
Acronym
Sentimag02
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Baden
Collaborators
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sienna+ retro and Technetium 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sienna+ peri and Technetium 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sienna+ retro 4-6 and Technetium 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sienna+ peri 4-6 and Technetium 1
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sienna+ retro
Intervention Description
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
Intervention Type
Device
Intervention Name(s)
Sienna+ peri
Intervention Description
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
Intervention Type
Device
Intervention Name(s)
Sienna+ retro 4-6
Intervention Description
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
Intervention Type
Device
Intervention Name(s)
Sienna+ peri 4-6
Intervention Description
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
Intervention Type
Device
Intervention Name(s)
Technetium 1
Intervention Description
Sentinel node marking with Technetium 1 day before surgery
Primary Outcome Measure Information:
Title
Detection rate per Patient
Description
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Number of lymph nodes excised
Description
Number of excised sentinel lymph nodes
Time Frame
During surgery
Title
Nodal detection rate
Description
Number of detected versus excised sentinel lymph nodes with either method.
Time Frame
During surgery
Title
Malignancy rate
Description
Number of histologically confirmed malignant sentinel lymph nodes detected with either method.
Time Frame
1-2 days post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nik Hauser, PD Dr.
Phone
+41 56 486 36 36
Email
brustzentrum@ksb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Leo, PD Dr. med.
Phone
+41 56 486 36 36
Email
brustzentrum@ksb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nik Hauser, PD Dr.
Organizational Affiliation
Kantonsspital Baden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nik Hauser, PD Dr.
Phone
+41 56 486 36 36
Email
brustzentrum@ksb.ch
Facility Name
Inselspital Bern, Universitätsklinik für Frauen.
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Sager, Dr. med.
Phone
+41 31 632 18 40
Email
patrizia.sager@insel.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
24484967
Citation
Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.
Results Reference
result
PubMed Identifier
24322530
Citation
Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.
Results Reference
result
PubMed Identifier
26365441
Citation
Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12385. Epub 2015 Sep 14.
Results Reference
result
PubMed Identifier
25466980
Citation
Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.
Results Reference
result

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Sienna+® Injection Time Study 4 Arms

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