Clinical trial · Interventional
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
- 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)
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery. The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Cancer | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrium Cancer | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Ovary Cancer | — | UNRESOLVED | — |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma, Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Vulva Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| Optonuclear probe | Device | — | UNRESOLVED |
| Quest Camera | Device | — | UNRESOLVED |
| Technetium99 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sentinel lymph node detection
- description
- Each patient receive both injections of Technetium99 (standard care) and indocyanine green. The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
- interventionNames
- Drug: Indocyanine green
- Drug: Technetium99
- Device: Optonuclear probe
- Device: Quest Camera
Primary outcomes (1)
- measure
- Non-inferiority of indocyanine green guided sentinel lymph node biopsy
- timeFrame
- 1 day
- description
- The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years * cancer histologically proved * patient eligible for sentinel node detection * contraceptive methods for men and women of childbearing age * signed informed consent form * patient affiliated to the social security system Exclusion Criteria: * neoadjuvant chemotherapy or hormone therapy * adenopathy (s) clinically suspicious or positively cytopenic * women who are pregnant or breast-feeding * associated pathology that may prevent patient of receive indocyanine green * ongoing participation in another clinical trial with an investigational drug * patients deprived of liberty or under supervision * impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
References
Publications (0)
Data not yet available