Clinical trial NCT02445456: Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
Official title: Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Sentinel Lymph Node Biopsy
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: Endomagnetics Ltd.
First posted: 2015-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Participants Experiencing of Adverse or Hypersensitivity Reaction
timeFrame: 5 days after injection
measure: Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery
timeFrame: at time of surgery
measure: Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon
timeFrame: at time of surgery
Secondary outcomes:
measure: Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location
timeFrame: 5 days after surgery
measure: Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node
timeFrame: 5 days after surgery
measure: High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
timeFrame: MRI scan done 2 hours after Sienna+ tracer injection
measure: Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Chris Cunningham, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: