Clinical trial · Interventional
Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
NCT02445456CI-TRIAL-00059490SentiRectterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistical difficulties in recruiting patients led to slower than expected recruitment. Recruitment was completely suspended during Covid and will not be restarted.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI scan | Other | — | UNRESOLVED |
| Sentimag probe | Device | — | UNRESOLVED |
| Sienna+ injection | Drug | — | UNRESOLVED |
| Surgery to excise rectal cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ex-vivo
- description
- 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.
- interventionNames
- Drug: Sienna+ injection
- Procedure: Surgery to excise rectal cancer
- Device: Sentimag probe
- type
- EXPERIMENTAL
- label
- In-vivo
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.