Clinical trial · Interventional
Fluorescence Targeted Pelvic Lymph Node Mapping
Investigating the Feasibility of Fluorescence Targeted Pelvic Lymph Node Mapping During Rectal Cancer Surgery
NCT03204994CI-TRIAL-00040025terminatedPhase 1 / Phase 2ClinicalTrials.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): Not able to recruit
Summary
Brief summary (as posted)
This study aims to assess the lymphatic drainage of rectal tumours by using ICG as a fluorescent non-specific marker. As a feasibility study, it will also assess its technique and timing along with its ability to assist in removing lymph nodes when it is clinically indicated.
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 |
|---|---|---|---|
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
| Lymph Node Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumour injection of ICG
- description
- Indocyanine green injection into tumour before or during surgery.
- interventionNames
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- Number & location of lymph nodes identified with and without fluorescent probe during rectal cancer surgery
- timeFrame
- 1 day
Secondary outcomes (2)
- measure
- Noise to background signal of lymph nodes compared with positivity of lymph nodes.
- timeFrame
- 1 day
- description
- Positivity defined as whether they contain metastatic disease or not.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Participant is undergoing elective curative surgery for rectal adenocarcinoma * Participant is willing and able to comply with study requirements Exclusion Criteria: * Participant has history of or known allergy to indocyanine green * Participant has history of or known allergy to iodides * Participant suffers from hyperthyroidism or has a benign thyroid tumour * Participant has renal failure * Female participant currently pregnant, planning pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.