SentiPen
Research type
Research Study
Full title
Testing the Feasibility of Sentimag®/Sienna+® for detecting Inguinal Sentinel Nodes in Penile Cancer (SentiPen)
IRAS ID
236925
Contact name
Vijay Sangar
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
3362, Research Registry
Duration of Study in the UK
0 years, 6 months, 23 days
Research summary
A sentinel node is one which drains fluid from a specific site of the body and is thought to be the first lymph node to be involved with cancer when cancer spreads to local lymphatics. Removing the sentinel node allows for the testing of cancer cells. If the node contains cancer then there is a significant chance that other lymph nodes in that area are involved and they can be removed. However, if the sentinel node is uninvolved then there is a high chance that there has been no spread to the first order lymph nodes and the patient can be observed safely without the need for major surgery.
Dynamic sentinel node biopsy (DSNB) is a technique which uses radioisotopes and a blue dye to detect the site of sentinel nodes, which can then be removed with minimal surgical trauma for pathological analysis. This technique is now established as standard practice in penile cancer. The Christie based penile cancer team have developed a modern service for patients with this disease using DSNB since 2009. This has allowed for hundreds of patients to avoid morbid surgery in the form of inguinal node dissection.
The purpose of the study is to see if a new method of identifying the Sentinel Lymph Node that uses an injection of a magnetic brown dye (Sienna+) known as Sentimag is as effective as the current standard dual technique (which involves a radioactive tracer and blue dye). Both the standard dual technique and Sentimag technique will be used together to see if they are equally effective in detecting the sentinel nodes.
In addition Sentimag if identified as equally effective as standard treatment will help reduce patient contact time, avoid exposure to radioactivity, risk of blue dye tattooing and anaphylaxis, as well as help improve the patient experience.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0026
Date of REC Opinion
25 Jan 2018
REC opinion
Favourable Opinion