Breast NeoplasmsPhase 4Sentimag02NCT02612870
Sienna+® Injection Time Study 4 Arms
A Phase 4 study testing Sienna+ retro, Sienna+ peri and Sienna+ retro 4-6 in people with Breast Neoplasms, run by Kantonsspital Baden at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Sienna+ retro, Sienna+ peri and Sienna+ retro 4-6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital Baden
Baden, 5404
Nik Hauser, PD Dr., +41 56 486 36 36, brustzentrum@ksb.ch
Inselspital Bern, Universitätsklinik für Frauen.
Bern, 3010
Patrizia Sager, Dr. med., +41 31 632 18 40, patrizia.sager@insel.ch
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Sienna+ retro, Sienna+ peri, Sienna+ retro 4-6, Sienna+ peri 4-6, Technetium 1
- Keywords
- Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sienna+ retroDevice
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
Sienna+ periDevice
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
Sienna+ retro 4-6Device
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
Sienna+ peri 4-6Device
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
Technetium 1Device
Sentinel node marking with Technetium 1 day before surgery
| Study group | Role | What they receive |
|---|---|---|
| Sienna+ retro and Technetium 1 | Active comparator | 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. Receives: Device: Sienna+ retro; Device: Technetium 1 |
| Sienna+ peri and Technetium 1 | Active comparator | 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. Receives: Device: Sienna+ peri; Device: Technetium 1 |
| Sienna+ retro 4-6 and Technetium 1 | Active comparator | 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. Receives: Device: Sienna+ retro 4-6; Device: Technetium 1 |
| Sienna+ peri 4-6 and Technetium 1 | Active comparator | 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. Receives: Device: Sienna+ peri 4-6; Device: Technetium 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate per Patient
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.
Measured: During surgery
Secondary outcomes (3)
Number of lymph nodes excised
Number of excised sentinel lymph nodes
Measured: During surgery
Nodal detection rate
Number of detected versus excised sentinel lymph nodes with either method.
Measured: During surgery
Malignancy rate
Number of histologically confirmed malignant sentinel lymph nodes detected with either method.
Measured: 1-2 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Nik Hauser, Kantonsspital Baden
- Investigators
- Nik Hauser, PD Dr., Principal investigator, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612870
- Sponsor's protocol ID
- Baden201512
- Acronym
- Sentimag02
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24484967Douek 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.
PubMed 24322530Ghilli 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.
PubMed 26365441Rubio 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.
PubMed 25466980
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02612870
- Acronym / sponsor ID
- Sentimag02 / Baden201512
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sienna+ retro and Technetium 1 | Active comparator | Device: Sienna+ retro, Device: Technetium 1Sienna+® 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+ peri and Technetium 1 | Active comparator | Device: Sienna+ peri, Device: Technetium 1Sienna+® 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+ retro 4-6 and Technetium 1 | Active comparator | Device: Sienna+ retro 4-6, Device: Technetium 1Sienna+® 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+ peri 4-6 and Technetium 1 | Active comparator | Device: Sienna+ peri 4-6, Device: Technetium 1Sienna+® 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sienna+ retroSentinel node marking with Sienna+ retro-mamillary 1 day before surgery | Device | Sienna+ retro and Technetium 1 |
| Sienna+ periSentinel node marking with Sienna+ peri-tumorally 1 day before surgery | Device | Sienna+ peri and Technetium 1 |
| Sienna+ retro 4-6Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery | Device | Sienna+ retro 4-6 and Technetium 1 |
| Sienna+ peri 4-6Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery | Device | Sienna+ peri 4-6 and Technetium 1 |
| Technetium 1Sentinel node marking with Technetium 1 day before surgery | Device | Sienna+ peri 4-6 and Technetium 1, Sienna+ peri and Technetium 1, Sienna+ retro 4-6 and Technetium 1, Sienna+ retro and Technetium 1 |
Primary outcome
Detection rate per Patient
Time frame: During surgery
Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.
3 secondary outcomes
Number of lymph nodes excised
Time frame: During surgery
Nodal detection rate
Time frame: During surgery
Malignancy rate
Time frame: 1-2 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Results publication: PubMed 24484967Thill 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 publication: PubMed 24322530Douek 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 publication: PubMed 26365441Ghilli 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 publication: PubMed 25466980Rubio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nik Hauser, PD Dr. principal investigator
Kantonsspital Baden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sienna+ retro, Sienna+ peri and Sienna+ retro 4-6 in people with Breast Neoplasms, run by Kantonsspital Baden at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nik Hauser, PD Dr. (+41 56 486 36 36, brustzentrum@ksb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate per Patient (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612870, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.