Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2016-02-29
2016-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
Sienna+ retro
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
Technetium 1
Sentinel node marking with Technetium 1 day before surgery
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.
Sienna+ peri
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
Technetium 1
Sentinel node marking with Technetium 1 day before surgery
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.
Sienna+ retro 4-6
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
Technetium 1
Sentinel node marking with Technetium 1 day before surgery
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.
Sienna+ peri 4-6
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Interventions
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Sienna+ retro
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
Sienna+ peri
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
Sienna+ retro 4-6
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
Sienna+ peri 4-6
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
Technetium 1
Sentinel node marking with Technetium 1 day before surgery
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
FEMALE
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Kantonsspital Baden
OTHER
Responsible Party
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Nik Hauser
Director Department of Gynecology and Obstetrics
Principal Investigators
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Nik Hauser, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Baden
Locations
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Kantonsspital Baden
Baden, , Switzerland
Inselspital Bern, Universitätsklinik für Frauen.
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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Baden201512
Identifier Type: -
Identifier Source: org_study_id