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
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|
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)|
|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|
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
- Proportion of successful sentinel node biopsies (SLNB, detection rate per patient) with either the magnetic or the standard technique [ Time Frame: 6 Months ]
- 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 ]
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
|Contact: Lorraine Jacques||01902 email@example.com|
|The Royal Wolverhampton NHS Trust||Recruiting|
|Wolverhampton, United Kingdom, WV10 0QP|
|Contact: R Vidya firstname.lastname@example.org|
|Contact: V Carter email@example.com|
|Principal Investigator:||Raghavan Vidya||The Royal Wolverhampton NHS Trust|