Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

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.

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.

Sienna+ injection

MRI scan of pelvis to detect spread of magnetic tracer

MRI scan

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

Surgery to excise rectal cancer

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

Sentimag probe

Chris Cunningham, MD FRCS

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.

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.

Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer

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

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

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

The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe.

A pathologist will identify the sentinel lymph node histologically and record whether this matches the location identified by the Sentimag probe which has been previously marked with a suture

Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation

Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible

University of Leeds

Endomagnetics Ltd.

Oxford University Hospitals NHS Trust

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.

Sienna+ injection: Endoscopic injection of magnetic tracer

MRI scan: MRI scan of pelvis to detect spread of magnetic tracer

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)

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

Ex-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.

Sienna+ injection: Endoscopic injection of magnetic tracer

MRI scan: MRI scan of pelvis to detect spread of magnetic tracer

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)

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

In-vivo

Total

Age category

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United Kingdom

Region of Enrollment

T component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan.

Pre-operative tumour T stage

N component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan.

Pre-operative N stage

Prior treatment

Tumour diameter

Tumour height above anal margin

Tumour location

Miss Helen Jones

Number of Participants Experiencing of Adverse or Hypersensitivity Reaction

Only patients who underwent surgery were analysed. Two patients in the ex-vivo group who were planned to have surgery did not proceed to surgery; instead they moved to a 'watch and wait' pathway after chemoradiation.

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

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

Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed.

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

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

tracer uptake by tumour

extraneous mucosal tracer uptake

tracer uptake by mesorectal nodes

Suspicious nodes on MRI after tracer injection

Only patients who had MRI scans done following tracer injection were included.

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

This measure only applies to the In-vivo group. Ex-vivo group did not undergo TEM surgery.

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

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subcutaneous injection of Sienna+ in the morning of operation day

Yolanda Chan, MBBS

The aim of this study is to evaluate a new method for the localization of breast cancer sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard techniques with radio-isotopes.

The use of radioisotope with or without blue dye has long become the gold standard for sentinel lymph node localization in the management of breast cancer. The latest evidence from a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its application and feasibility has yet been tried in most Asian countries.

This is a prospective paired comparison trial involving both the new magnetic technique and the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation, followed by five minutes of massage to the injection site. Before incision, on-table transcutaneous detection with the handheld magnetometer are carried out after at least 20 minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with localization by radioisotope. All lymph nodes excised will be sent for histopathological examination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer	NCT02445456	Rectal Cancer	Sienna+ injecti... MRI scan Surgery to exci... Sentimag probe	18 Years - 90 Years	Oxford University Hospitals NHS Trust
Sienna and Sentimag in Sentinel Lymph Node Biopsy	NCT03036475	Breast Cancer	Sienna+ injecti...	18 Years -	Kwong Wah Hospital

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