Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

NCT02445456 | Terminated Results

• 1 other identifier: R37025/CN339
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing of Adverse or Hypersensitivity Reaction

  Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection

  5 days after injection

• Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery

  Assess frequency of Sienna+ tracer being detectable at the tumour injection site and in the lymph nodes at the time of surgery

  at time of surgery

• Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon

  Surgeon's qualitative assessment of any difficulties encountered during surgery which could be attributable to prior injection of the tracer, such as pigmentation or fibrosis making surgery more difficult than normal

  at time of surgery

Secondary Outcomes (4)

• Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location

  5 days after surgery

• Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node

  5 days after surgery

• High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum

  MRI scan done 2 hours after Sienna+ tracer injection

• Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed

  at time of surgery

Study Arms (2)

Ex-vivo

EXPERIMENTAL

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.

Drug: Sienna+ injection; Procedure: Surgery to excise rectal cancer; Device: Sentimag probe

In-vivo

EXPERIMENTAL

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.

Drug: Sienna+ injection; Other: MRI scan; Procedure: Surgery to excise rectal cancer; Device: Sentimag probe

Interventions

Sienna+ injection DRUG

Endoscopic injection of magnetic tracer

Ex-vivo; In-vivo

MRI scan OTHER

MRI scan of pelvis to detect spread of magnetic tracer

In-vivo

Surgery to excise rectal cancer PROCEDURE

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

Ex-vivo; In-vivo

Sentimag probe DEVICE

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

Ex-vivo; In-vivo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Leeds: collaborator
• Endomagnetics Ltd.: collaborator

Study Sites (1)

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Miss Helen Jones
• Organization: Oxford University Hospitals NHS Foundation Trust

helen.jones3@ouh.nhs.uk

01865 235657

Study Officials

• Chris Cunningham, MD FRCS

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 6, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)