Clinical trial · Interventional
Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG
Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MultiSpectral Optoacoustic Tomography (MSOT) and IndoCyanine Green (ICG)
NCT05467137CI-TRIAL-00059743MelanooMSOTunknownPhase 4ClinicalTrials.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)
In this study the investigators try to identify the sentinel lymph node in patients with stage Ib-III melanoma in a non-invasive manner without the use of a radioactive tracer by using the new MSOT technology.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSOT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard of care + MSOT
- description
- Standard of care + MSOT
- interventionNames
- Device: MSOT
Primary outcomes (1)
- measure
- Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard of care with 99mTc-nanocolloid Tc99m and lymphoscintigraphic imaging
- timeFrame
- Through study completion (an average of 1 year)
Secondary outcomes (1)
- measure
- Patient characteristics
- timeFrame
- Through study completion (an average of 1 year)
- description
- Age, sex, BMI, history and morbidity, localization and extent of primary tumor, baseline blood count/liver and kidney function
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with grade Ib- III melanoma scheduled for SLNB and/or surgical excision. * Patients must be \> 18 years old and be able to give informed consent. * Skintype I-IV following Fitzpatrick skin classification (MSOT less reliable in skin types \>IV) Exclusion Criteria: * Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland * Prior surgery or radiotherapy on involved lymph nodes / area * Major surgery within 28 days before tracer administration * Pregnant or nursing women, fertile women will need a negative pregnancy test prior to inclusion * History of iodine allergy or anaphylactic reactions to insect bites * Hypersensitivity to ICG or poorly tolerated ICG in the past * Unexplained allergic reaction in the past * Skin type \>IV following Fitzpatrick skin classification (MSOT less reliable)
References
Publications (0)
Data not yet available
No reference posted for this study.