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NCT05676788
HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections
Conditions: Lung Neoplasm, Pulmonary Metastasis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: LungenClinic Grosshansdorf
Location: Germany
Summary
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.
Eligibility Criteria
Inclusion Criteria:Histologically confirmed lung cancer stage I/II or malignancy suspicious nodulesSegmentectomy is oncologically indicated or impaired pulmonary and/or cardiac function prevent anatomical resectionMale or female patients aged ≥ 18 years without upper age limitSerum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance (CrCl ≥ 50 mL/min, Cockcroft-Gault formula)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)Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) ≤ 2.5 x upper limit of normalFull legal capacityWritten informed consent obtained according to international guidelines and local lawsAbility to understand the nature of the trial and the trial related procedures and to comply with themExclusion Criteria:Requirement of a lobectomy or pneumonectomy to achieve complete resectionAllergy to indocyanine green or iodineHyperthyroidismCurrent or planned pregnancy, nursing period (if defined as requirement of clinical routine treatment)Medical condition which poses a high risk to undergo surgery as defined by the investigatorCovid19 / SARS-CoV2-infection at time of screeningParticipation in any other interventional clinical trial within the last 30 days before the start of this trialSimultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowedKnown or persistent abuse of medication, drugs or alcoholPerson who is in a relationship of dependence/employment with the coordinating investigator or the investigator
Source: ClinicalTrials.gov (NCT05676788). StuddyBuddy aggregates publicly available trial information.