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Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

NCT02445456 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-07-06

Study results available
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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.

Conditions

Interventions

DRUG

Sienna+ injection

Endoscopic injection of magnetic tracer

OTHER

MRI scan

MRI scan of pelvis to detect spread of magnetic tracer

PROCEDURE

Surgery to excise rectal cancer

Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)

DEVICE

Sentimag probe

Probe to detect the previously injected magnetic tracer (Sienna+)

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Endomagnetics Ltd.

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Chris Cunningham, MD FRCS · Oxford University Hospitals NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445456 on ClinicalTrials.gov