Clinical trial · Interventional
Radioisotope and Fluorescence Guidance in Rectal Cancer
Pelvic Side Wall Lymph Node Detection in Rectal Cancer Using Dual Radioisotope and Fluorescence Guidance
NCT05336643CI-TRIAL-00061874unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to investigate if pelvic side wall lymph nodes that remain after neo-adjuvant chemoradiotherapy can be identified intraoperatively using dual radioisotope and fluorescence guidance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofluorescence | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radioisotope and fluorescence guidance
- description
- Patients undergoing curative resection for rectal cancer will receive a peritumoural, submucosal administration of indocyanine green and technetium-99m nanocolloid. Intraoperatively the SENSEI gamma probe and Da Vinci Firefly will be used to identify pelvic side wall lymph nodes.
- interventionNames
- Device: Radiofluorescence
Primary outcomes (2)
- measure
- Lymph node detection with indocyanine green and near-infrared light source
- timeFrame
- 12 months
- description
- Intraoperative identification of pelvic side wall lymph nodes using fluorescence. After resection of the rectal specimen the near infrared light source will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT. Primary outcome will be recorded as "yes" or "no".
- measure
- Lymph node detection with technetium 99m colloid and SENSEI gamma probe
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Primary diagnosis of biopsy-proven rectal cancer * Scheduled for curative robotic surgery of primary tumour * Have signed an approved informed consent form for the study * Be willing and able to comply with the study protocol Exclusion Criteria: * Known allergy or history of adverse reaction to Technetium-99m nanocolloid or indocyanine green * Pregnant or lactating subjects * Subjects who, in the Investigator's and/or designee's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results
References
Publications (0)
Data not yet available
No reference posted for this study.