HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections

NCT05676788 | Not Yet Recruiting DMC

• 1 other identifier: HSI_01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm; Pulmonary Metastasis

Keywords

Hyperspectral Imaging; Lung cancer; Segmentectomy; Indocyanine green; Intersegmental plane; Machine learning strategies

Outcome Measures

Primary Outcomes (1)

• Intersegmental Plane identification

  Distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence

  directly before pulmonary intersegmental plane dissection

Secondary Outcomes (2)

• Tumor distance [mm]

  immediately after surgery

• 7-item binary rating scale for feasibilty of HSI measurement

  immediately after surgery

Other Outcomes (2)

• Machine Learning

  one week after surgery

• Safety of HSI

  at 10 days and 6 weeks after surgery

Study Arms (1)

Intersegmental plane identification by HSI and ICG

EXPERIMENTAL

Hyperspectral Imaging Intersegmental plane identification: Defined as distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence.

Device: Hyperspectral Imaging

Interventions

Hyperspectral Imaging DEVICE

Identification of the intersegmental plane

Intersegmental plane identification by HSI and ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed lung cancer stage I/II or malignancy suspicious nodules
• Segmentectomy is oncologically indicated or impaired pulmonary and/or cardiac function prevent anatomical resection
• Male or female patients aged ≥ 18 years without upper age limit
• Serum 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 normal
• Full legal capacity
• Written informed consent obtained according to international guidelines and local laws
• Ability to understand the nature of the trial and the trial related procedures and to comply with them

You may not qualify if:

• Requirement of a lobectomy or pneumonectomy to achieve complete resection
• Allergy to indocyanine green or iodine
• Hyperthyroidism
• Current 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 investigator
• Covid19 / SARS-CoV2-infection at time of screening
• Participation in any other interventional clinical trial within the last 30 days before the start of this trial
• Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
• Known or persistent abuse of medication, drugs or alcohol
• Person who is in a relationship of dependence/employment with the coordinating investigator or the investigator

Sponsors & Collaborators

• LungenClinic Grosshansdorf: lead
• Institute of Medical Technology and Intelligent Systems, Hamburg University of Technology, Germany: collaborator

Study Sites (1)

LungenClinic Großhansdorf

Großhansdorf, 22927, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Hyperspectral Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

David B Ellebrecht, MD

CONTACT

+4941026012201; d.ellebrecht@lungenclinic.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: January 9, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

DE (1)