Rectal CancerSentiRectNCT02445456
Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
A study testing Sienna+ injection, MRI scan and Surgery to excise rectal cancer in people with Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Sienna+ injection, MRI scan and Surgery to excise rectal cancer
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Sienna+ injection, MRI scan, Surgery to excise rectal cancer, Sentimag probe
- Keywords
- Rectal cancer, Sentinel Lymph Node Biopsy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sienna+ injectionDrug
Endoscopic injection of magnetic tracer
MRI scanOther
MRI scan of pelvis to detect spread of magnetic tracer
Surgery to excise rectal cancerProcedure or surgery
Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
Sentimag probeDevice
Probe to detect the previously injected magnetic tracer (Sienna+)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sienna+ injection; Other: MRI scan; Procedure: Surgery to excise rectal cancer; Device: Sentimag probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing of Adverse or Hypersensitivity Reaction
Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection
Measured: 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
Measured: 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
Measured: 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
The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe.
Measured: 5 days after surgery
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
Measured: 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
Measured: 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
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Logistical difficulties in recruiting patients led to slower than expected recruitment. Recruitment was completely suspended during Covid and will not be restarted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, Endomagnetics Ltd.
- Responsible party
- Principal investigator, Chris Cunningham, Oxford University Hospitals NHS Trust
- Investigators
- Chris Cunningham, MD FRCS, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445456
- Sponsor's protocol ID
- R37025/CN339
- Acronym
- SentiRect
- Status last verified
- Jun 2022
- First submitted
- 1 May 2015
- Last updated
- 6 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT02445456
- Acronym / sponsor ID
- SentiRect / R37025/CN339
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Sentinel Lymph Node Biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical difficulties in recruiting patients led to slower than expected recruitment. Recruitment was completely suspended during Covid and will not be restarted.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Leeds, Endomagnetics Ltd.
- Study start
- Dec 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex-vivo | Experimental | Drug: Sienna+ injection, Procedure: Surgery to excise rectal cancer, Device: Sentimag probePatients 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 | Drug: Sienna+ injection, Other: MRI scan, Procedure: Surgery to excise rectal cancer, Device: Sentimag probePatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sienna+ injectionEndoscopic injection of magnetic tracer | Drug | Ex-vivo, In-vivo |
| MRI scanMRI scan of pelvis to detect spread of magnetic tracer | Other | In-vivo |
| Surgery to excise rectal cancerSurgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM) | Procedure or surgery | Ex-vivo, In-vivo |
| Sentimag probeProbe to detect the previously injected magnetic tracer (Sienna+) | Device | Ex-vivo, In-vivo |
Primary outcome
Number of Participants Experiencing of Adverse or Hypersensitivity Reaction
Time frame: 5 days after injection
Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection
Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery
Time frame: at time of surgery
Assess frequency of Sienna+ tracer being detectable at the tumour injection site and in the lymph nodes at the time of surgery
Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon
Time frame: at 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
4 secondary outcomes
Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location
Time frame: 5 days after surgery
Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node
Time frame: 5 days after surgery
High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum
Time frame: MRI scan done 2 hours after Sienna+ tracer injection
Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed
Time frame: at time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Cunningham, MD FRCS principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sienna+ injection, MRI scan and Surgery to excise rectal cancer in people with Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing of Adverse or Hypersensitivity Reaction (time frame: 5 days after injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.