HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections

Launched by LUNGENCLINIC GROSSHANSDORF · Jan 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help doctors identify specific areas in the lungs during surgery for lung cancer. The study focuses on using advanced technology called Hyperspectral Imaging to locate these areas better than the current method, which uses a dye called ICG (indocyanine green). The goal is to make lung surgeries safer and more effective by also using machine learning to guide the surgeons during the procedure.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of early-stage lung cancer or suspicious lung nodules that require surgery. You can be of any gender and should not have serious health issues that could complicate surgery. If you join the trial, you will receive information about the procedures and will need to give your consent to participate. The trial is not yet recruiting participants, but it aims to improve how surgeries are done in the future.

Gender

ALL

Eligibility criteria

• 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