Clinical trial NCT02612870: Sienna+® Injection Time Study 4 Arms
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Sentinel Node
Sentinel Node Biopsy
Breast Surgery
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2015-11-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection rate per Patient
timeFrame: During surgery
Secondary outcomes:
measure: Number of lymph nodes excised
timeFrame: During surgery
measure: Nodal detection rate
timeFrame: During surgery
measure: Malignancy rate
timeFrame: 1-2 days post surgery
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Berne
country: Switzerland
facility: Inselspital Bern, Universitätsklinik für Frauen.
Study officials:
affiliation: Kantonsspital Baden
name: Nik Hauser, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.