Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

NCT ID: NCT02445456

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-12-31

Brief 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.

Detailed Description

One issue in managing rectal cancer is identifying which patients will benefit from less radical surgery, which is much safer and better tolerated. However it does not remove lymph nodes where cancer cells may have spread. If lymph nodes containing cancer are left behind, the cancer may recur. So this surgery is only suitable in early rectal cancers not involving lymph nodes. Unfortunately, current investigations do not always accurately identify involved lymph nodes.

Sentinel lymph node biopsy (SLNB) is a technique to surgically remove the first lymph node where cancer cells spread. If this lymph node contains cancer, radical surgery is needed to reduce the risk of recurrence. However if it is clear, less radical surgery should be sufficient. This is standard practice for breast cancer and avoids unnecessary major surgery in many patients.

The investigators aim to assess whether SLNB is useful in rectal cancer. The investigators will determine whether the Sienna+/Sentimag system effectively identifies the sentinel lymph node, and whether the node can then be removed surgically.

The investigators will recruit patients in Oxford hospitals about to undergo surgery for rectal cancer. Patients will receive an injection of magnetic tracer during endoscopy prior to surgery. Some patients will have an extra MRI scan. During or after surgery, depending on the type of operation planned, a magnetic probe will be used to locate the sentinel lymph node in the tissue around the rectum. The removed specimen will be examined by a pathologist. Funding to undertake this study has been granted by the National Institute for Health Research (NIHR). Endomagnetics, the manufacturer, will supply the magnetic tracer and probe for use in this study.

If successful, the investigators will plan a larger clinical trial. This could have a major impact on improving outcomes for patients by allowing less radical surgery to be used where it is most appropriate.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ex-vivo

Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.

Group Type: EXPERIMENTAL

Sienna+ injection

Intervention Type: DRUG

Endoscopic injection of magnetic tracer

Surgery to excise rectal cancer

Intervention Type: PROCEDURE

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

Sentimag probe

Intervention Type: DEVICE

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

In-vivo

Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.

Group Type: EXPERIMENTAL

Sienna+ injection

Intervention Type: DRUG

Endoscopic injection of magnetic tracer

MRI scan

Intervention Type: OTHER

MRI scan of pelvis to detect spread of magnetic tracer

Surgery to excise rectal cancer

Intervention Type: PROCEDURE

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

Sentimag probe

Intervention Type: DEVICE

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

Interventions

Sienna+ injection

Endoscopic injection of magnetic tracer

Intervention Type: DRUG

MRI scan

MRI scan of pelvis to detect spread of magnetic tracer

Intervention Type: OTHER

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)

Intervention Type: PROCEDURE

Sentimag probe

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

Endomagnetics Ltd.

INDUSTRY

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Chris Cunningham

Mr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Cunningham, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

Churchill Hospital

Oxford, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R37025/CN339

Identifier Type: -

Identifier Source: org_study_id