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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sentinel Node
• Intervention / Treatment: Device: Sentimag Device

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
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique	6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Collaborators: Sysmex Medical
• Investigators: Principal Investigator: Raghavan Vidya, The Royal Wolverhampton NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sentinel lymph node biopsy (SLNB); Superparamagnetic iron oxide (SPIO) tracer
• Other Study ID Numbers: 2015SUR79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided