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The Efficacy of Sentimag in Detection of Sentinel Node Biopsy (SMART)

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ClinicalTrials.gov Identifier: NCT02739425
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Sysmex Medical
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Sentinel Node Device: Sentimag Device Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 283 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SMART Study: Sentimag Along With Routine Technique in Detection of Sentinel Node Biopsy
Actual Study Start Date : September 22, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Standard Procedure plus use of sentimag
Detection of the nodes carried out using the gamma probe and also the sentimag - all patients receive both diagnostic interventions
Device: Sentimag Device
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




Primary Outcome Measures :
  1. Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Detection rate per node [ Time Frame: 6 Months ]
  2. Malignancy rate: proportion of nodes and patients with a malignant result in the definite pathological analysis. [ Time Frame: 6 Months ]
  3. Concordance rate: proportion of successful labelling with the standard and new technique per patient and per node [ Time Frame: 6 Months ]
  4. Malignancy concordance: proportion of successful labelling with the standard and new technique per malignancy positive patients and nodes [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739425


Contacts
Contact: Lorraine Jacques 01902 695064 lorraine.jacques@nhs.net

Locations
United Kingdom
The Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: R Vidya       raghavan.vidya@nhs.net   
Contact: V Carter       vanda.carter@nhs.net   
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Sysmex Medical
Investigators
Principal Investigator: Raghavan Vidya The Royal Wolverhampton NHS Trust

Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02739425     History of Changes
Other Study ID Numbers: 2015SUR79
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The Royal Wolverhampton Hospitals NHS Trust:
Sentinel lymph node biopsy (SLNB)
Superparamagnetic iron oxide (SPIO) tracer