Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope

NCT06007261 | Recruiting

• 1 other identifier: IMAGIO-VALIDIAG
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to verify a new microscopic technique in diagnosing patients suspected of lung cancer. Patients will undergo navigational bronchoscopy or surgical resection as a part of standard of care. Biopsies taken during this procedure will be imaged for a few minutes with a higher harmonic generation (HHG) microscope, after which the material is taken to the pathology department for histopathology assessment, which is currently the golden standard for diagnosis.

Conditions

Lung Cancer

Keywords

Navigation Bronchoscopy; Higher harmonic generation microscopy; Artificial intelligence; Diagnostics; Surgical resection

Outcome Measures

Primary Outcomes (2)

• The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist

  Accuracy of HHG microscopy obtained and assessed images for diagnosing pathology as compared against golden standard routine clinical follow up pathology tissue evaluation techniques (H\&E staining and if used, additional stains), as judged by the pathologist.

  48 months

• The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.

  Accuracy of HHG microscopy image based AI algorithm for autonomous diagnosis of pathology as compared against diagnosis of conventional golden standard routine clinical follow up pathology tissue evaluation techniques (H\&E staining and if used, additional stains).

  48 months

Secondary Outcomes (1)

• The ability to obtain a diagnosis from HHG microscopy images as judged during the procedure (rapid on-site) by the cyto-technician or pathologist.

  48 months

Eligibility Criteria

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

Study Population

The study population will consist of patients with a pulmonary lesion(s) with an indication for surgical resection according to guideline recommended care, multi-discplinary tumor board decision making and patient preferences. Median age will be approximately 65 years. Sex distribution will be approximately 50-60% male, 40-50% female based on prior studies at the Radboudumc.

You may qualify if:

• ASA physical status 1-3.
• Age 18 years or older.
• A pulmonary lesion with an indication for diagnostic or therapeutic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

You may not qualify if:

• Bleeding disorders.
• Less than 18 years old.
• Inability to consent.
• Unfit for navigation bronchoscopy and/or unfit for surgical resection as per guideline recommended care and multi-disciplinary tumor board decision making.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Flash Pathology BV: collaborator
• VU University of Amsterdam: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erik HFM van der Heijden, Prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roel LJ Verhoeven, PhD

CONTACT

0031627495531; roel.lj.verhoeven@radboudumc.nl

Judith JM Leermakers-Ceelen, PhD

CONTACT

0031631117495; Judith.Leermakers-Ceelen@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 23, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

NL (1)