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Logistical difficulties in recruiting patients led to slower than expected recruitment. Recruitment was completely suspended during Covid and will not be restarted.
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| Name | Class |
|---|---|
| University of Leeds | OTHER |
| Endomagnetics Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sienna+ injection | Drug | Endoscopic injection of magnetic tracer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location | The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe. | 5 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Cunningham, MD FRCS | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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+) |
| FG001 | 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. 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+) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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+) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing of Adverse or Hypersensitivity Reaction | Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection | Posted | Count of Participants | Participants | 5 days after injection |
|
Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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+) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Helen Jones | Oxford University Hospitals NHS Foundation Trust | 01865 235657 | helen.jones3@ouh.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2019 | Oct 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| MRI scan |
| Other |
MRI scan of pelvis to detect spread of magnetic tracer |
|
| 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) |
|
| Sentimag probe | Device | Probe to detect the previously injected magnetic tracer (Sienna+) |
|
| Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node |
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 |
| 5 days after surgery |
| High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum | Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation | MRI scan done 2 hours after Sienna+ tracer injection |
| Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed | Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible | at time of surgery |
| BG001 | 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. 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+) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-operative tumour T stage | T component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan. | Count of Participants | Participants |
|
| Pre-operative N stage | N component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan. | Count of Participants | Participants |
|
| Prior treatment | Count of Participants | Participants |
|
| Tumour diameter | Median | Full Range | centimeter |
|
| Tumour height above anal margin | Median | Full Range | centimeter |
|
| Tumour location | Count of Participants | Participants |
|
| OG001 | 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. 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+) |
|
|
| Primary | 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 | 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. | Posted | Number | operations | at time of surgery | Operations | Operations |
|
|
|
| Primary | 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 | 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. | Posted | Number | operations | at time of surgery | Operations | Operations |
|
|
|
| Secondary | Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location | The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe. | Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed. | Posted | Number | surgical mesorectal specimen | 5 days after surgery | Surgical mesorectal specimens | Surgical mesorectal specimens |
|
|
|
| Secondary | Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node | 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 | Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed. | Posted | Number | surgical mesorectal specimen | 5 days after surgery | Surgical mesorectal specimens | Surgical mesorectal specimens |
|
|
|
| Secondary | High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum | Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation | Only patients who had MRI scans done following tracer injection were included. | Posted | Number | MRI scans | MRI scan done 2 hours after Sienna+ tracer injection | MRI scans | MRI scans |
|
|
|
| Secondary | Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed | Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible | This measure only applies to the In-vivo group. Ex-vivo group did not undergo TEM surgery. | Posted | Number | TEM operations | at time of surgery | TEM operations | TEM operations |
|
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|
| 0 |
| 13 |
| 4 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. 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+) | 0 | 2 | 0 | 2 | 0 | 2 |
| Anastomotic leak | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| mrT3 - tumour has grown into the outer lining of the bowel wall |
|
| mrN2 - more than 3 lymph nodes contain cancer cells |
|
| Local excision |
|
| posterior |
|
| tracer uptake by mesorectal nodes |
|
| Suspicious nodes on MRI after tracer injection |
|