Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer, is effective in identifying the sentinel lymph node in rectal cancer and whether it is then feasible to remove this lymph node during surgery to locally excise early rectal cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: Endomagnetics Limited; Endomagnetics Ltd.; University of Leeds

Criteria

Inclusion Criteria:

• diagnosed with operable rectal cancer

• case discussed at Oxford Colorectal Cancer multi-disciplinary team (MDT) meeting

• willing and able to give informed consent

• willing and able to comply with all trial requirements, in the investigator's opinion

Exclusion Criteria:

• females who are pregnant or lactating

• known intolerance or hypersensitivity to iron, dextran compounds, magnetic tracers or superparamagnetic iron oxide particles (SPIO)

• cancer involvement of anal sphincter complex

• adults who are not able to give consent or are deemed vulnerable