Breast CancerSMARTNCT02739425
The Efficacy of Sentimag in Detection of Sentinel Node Biopsy
A study testing Sentimag Device in people with Breast Cancer and Sentinel Node, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Sentinel Node
- What is being tested?
- Sentimag Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2016to 1 May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary breast cancer scheduled for Sentinel node biopsy;
- Patients who are clinically and radiologically node negative;.
- Patients aged ≥18 years at time of consent
- Patients are able and willing to give informed consent
- Ability and willingness to undertake all scheduled visits and assessments
Who cannot join
- Patients who are currently Pregnantcy or lactatingon;
- Patients with metastatic cancer;
- Subject has a known hypersensitivity to blue dye;
- Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+
- Patients who have iron overload disease;
- Patients who has a pacemaker or other implantable device in the chest wall or shoulder;
Show all 9Show fewer
- Previous axilla surgery, or impaired lymphatic function
- Subject is deprived of liberty or under guardianship
- Subject is indicated or scheduled for post-operative MRI investigation of the breast
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: SMART Study: Sentimag Along With Routine Technique in Detection of Sentinel Node Biopsy
The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping.
The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.
Read the detailed description
Sentinel lymph node biopsy (SLNB) is now the standard technique used in breast cancer patients with a clinically and radiologically negative axilla. SLNB for breast cancer was introduced in the 1990s3 and it significantly reduces the morbidity associated with axillary node dissection (ALND) including lymphedema, seroma, numbness, wound infection, reduced shoulder motility, and chronic pain.2 The gold standard for sentinel node detection is the 'combined technique'; using both blue dye and radioisotope injection. After allowing both radioisotope and blue dye to localize in the lymphatic system, the clinician uses a 'gamma probe' (a handheld scintillation counter) to locate the SLNs. The blue dye assists in localisation post-incision, with lymph nodes that are blue and/or radioactive are judged as 'SLNs' and excised. Some centres use either radioisotope or blue dye alone. Although detection rates are lower, they can still reach satisfying values in experienced centres.
The use of radioisotope exposes patients and healthcare workers to radiation, is heavily controlled by legislation (both on the specific training for operators and subsequent disposal of surgical waste), and provides poor pre-operative imaging. As a result, many centres have stopped undertaking routine pre-operative lymphoscintigraphy. There is thus a clinical need to develop new techniques for detecting sentinel nodes without these drawbacks.
- Conditions
- Breast Cancer, Sentinel Node
- Being tested
- Sentimag Device
- Keywords
- Sentinel lymph node biopsy (SLNB), Superparamagnetic iron oxide (SPIO) tracer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentimag DeviceDevice
The programme will compare the Sentimag with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB
| Study group | Role | What they receive |
|---|---|---|
| Standard Procedure plus use of sentimag | Other | Detection of the nodes carried out using the gamma probe and also the sentimag - all patients receive both diagnostic interventions Receives: Device: Sentimag Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique
Measured: 6 Months
Secondary outcomes (4)
Detection rate per node
Measured: 6 Months
Malignancy rate: proportion of nodes and patients with a malignant result in the definite pathological analysis.
Measured: 6 Months
Concordance rate: proportion of successful labelling with the standard and new technique per patient and per node
Measured: 6 Months
Malignancy concordance: proportion of successful labelling with the standard and new technique per malignancy positive patients and nodes
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start22 Sep 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Sysmex Medical
- Responsible party
- Sponsor
- Investigators
- Raghavan Vidya, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739425
- Sponsor's protocol ID
- 2015SUR79
- Acronym
- SMART
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2016
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Study: Sentimag Along With Routine Technique in Detection of Sentinel Node Biopsy
- ClinicalTrials.gov ID
- NCT02739425
- Acronym / sponsor ID
- SMART / 2015SUR79
- Conditions
- Breast Cancer, Sentinel Node
- Keywords
- Sentinel lymph node biopsy (SLNB), Superparamagnetic iron oxide (SPIO) tracer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- Sysmex Medical
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 15 Apr 2016 (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.
The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping.
The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.
Detailed description
Sentinel lymph node biopsy (SLNB) is now the standard technique used in breast cancer patients with a clinically and radiologically negative axilla. SLNB for breast cancer was introduced in the 1990s3 and it significantly reduces the morbidity associated with axillary node dissection (ALND) including lymphedema, seroma, numbness, wound infection, reduced shoulder motility, and chronic pain.2 The gold standard for sentinel node detection is the 'combined technique'; using both blue dye and radioisotope injection. After allowing both radioisotope and blue dye to localize in the lymphatic system, the clinician uses a 'gamma probe' (a handheld scintillation counter) to locate the SLNs. The blue dye assists in localisation post-incision, with lymph nodes that are blue and/or radioactive are judged as 'SLNs' and excised. Some centres use either radioisotope or blue dye alone. Although detection rates are lower, they can still reach satisfying values in experienced centres.
The use of radioisotope exposes patients and healthcare workers to radiation, is heavily controlled by legislation (both on the specific training for operators and subsequent disposal of surgical waste), and provides poor pre-operative imaging. As a result, many centres have stopped undertaking routine pre-operative lymphoscintigraphy. There is thus a clinical need to develop new techniques for detecting sentinel nodes without these drawbacks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Procedure plus use of sentimag | Other | Device: Sentimag DeviceDetection of the nodes carried out using the gamma probe and also the sentimag - all patients receive both diagnostic interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with primary breast cancer scheduled for Sentinel node biopsy;
- Patients who are clinically and radiologically node negative;.
- Patients aged ≥18 years at time of consent
- Patients are able and willing to give informed consent
- Ability and willingness to undertake all scheduled visits and assessments
Key exclusion criteria (9 listed)
- Patients who are currently Pregnantcy or lactatingon;
- Patients with metastatic cancer;
- Subject has a known hypersensitivity to blue dye;
- Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+
- Patients who have iron overload disease;
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 |
|---|---|---|
| Sentimag DeviceThe programme will compare the Sentimag with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB | Device | Standard Procedure plus use of sentimag |
Primary outcome
Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique
Time frame: 6 Months
4 secondary outcomes
Detection rate per node
Time frame: 6 Months
Malignancy rate: proportion of nodes and patients with a malignant result in the definite pathological analysis.
Time frame: 6 Months
Concordance rate: proportion of successful labelling with the standard and new technique per patient and per node
Time frame: 6 Months
Malignancy concordance: proportion of successful labelling with the standard and new technique per malignancy positive patients and nodes
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
Raghavan Vidya principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentimag Device in people with Breast Cancer and Sentinel Node, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2019.