Clinical trial · Interventional
HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections
Hyperspectral Imaging for Intersegmental Plane Identification During Sublobar Pulmonary Resections in Lung Cancer Patients
- 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)
The purpose of this study is the identification of the intersegmental plane and navigation during sublobar pulmonary resections in lung cancer using Hyperspectral Imaging, the comparison with ICG fluorescence intersegmental plane identification, and the establishment of automatic intersegmental plane navigation using machine learning strategies for intraoperative navigation.
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 |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pulmonary Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperspectral Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intersegmental plane identification by HSI and ICG
- description
- Hyperspectral Imaging Intersegmental plane identification: Defined as distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence.
- interventionNames
- Device: Hyperspectral Imaging
Primary outcomes (1)
- measure
- Intersegmental Plane identification
- timeFrame
- directly before pulmonary intersegmental plane dissection
- description
- Distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence
Secondary outcomes (2)
- measure
- Tumor distance [mm]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed lung cancer stage I/II or malignancy suspicious nodules 2. Segmentectomy is oncologically indicated or impaired pulmonary and/or cardiac function prevent anatomical resection 3. Male or female patients aged ≥ 18 years without upper age limit 4. Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance (CrCl ≥ 50 mL/min, Cockcroft-Gault formula) 5. Total bilirubin ≤ 1.5 x upper limit of normal (except patients with Gilbert Syndrome (Morbus Meulengracht) in whom total bilirubin \< 3.0 mg/dL is allowed) 6. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) ≤ 2.5 x upper limit of normal 7. Full legal capacity 8. Written informed consent obtained according to international guidelines and local laws 9. Ability to understand the nature of the trial and the trial related procedures and to comply with them Exclusion Criteria: 1. Requirement of a lobectomy or pneumonectomy to achieve complete resection 2. Allergy to indocyanine green or iodine 3. Hyperthyroidism 4. Current or planned pregnancy, nursing period (if defined as requirement of clinical routine treatment) 5. Medical condition which poses a high risk to undergo surgery as defined by the investigator 6. Covid19 / SARS-CoV2-infection at time of screening 7. Participation in any other interventional clinical trial within the last 30 days before the start of this trial 8. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 9. Known or persistent abuse of medication, drugs or alcohol 10. Person who is in a relationship of dependence/employment with the coordinating investigator or the investigator
References
Publications (0)
Data not yet available