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Clinical Trials in Germany / NCT05676788
Starting soon Not applicable

HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections

NCT05676788 · tracked via the Priya Life Science Germany tracker
Sponsor
LungenClinic Grosshansdorf
Phase
Not applicable
Started
2023-04
Last updated
2023-01-09

Condition(s) studied

Lung NeoplasmPulmonary Metastasis

Investigational drug(s) / intervention(s)

Hyperspectral Imaging

Hyperspectral Imaging: Identification of the intersegmental plane

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
LungenClinic Großhansdorf Großhansdorf Germany

More LungenClinic Grosshansdorf trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05676788 on ClinicalTrials.gov ↗ ← All trials in Germany