Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules

Terminated

• Conditions: Solitary Pulmonary Nodule; Lung Cancer; Multiple Pulmonary Nodules

• Registration Number: NCT05066776
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

The purpose of this study is to determine if a liquid biopsy, a method of detecting cancer from a blood draw, combined with a PET/CT scan, a type of radiological scan, is better at determining whether a lung nodule is cancerous when compared to a PET/CT scan alone. A PET/CT scan is already used for diagnosis of lung nodules, but its efficacy is uncertain in nodules 6-20 mm in size. Therefore, the PET/CT will be evaluated for its diagnostic ability in lesions this size alone and in combination with a liquid biopsy. Secondarily, a machine learning model will be created to see if the combination of the PET/CT imaging data and the liquid biopsy data can predict the presence of cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Over 18 years of age

• ECOG performance status of 0,1, or 2

• Newly discovered lung nodule with:

  1. At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT
  2. No single lesion larger than 20 mm in greatest diameter when multiple nodules present
  3. High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines

• Able to provide informed consent

Exclusion Criteria

• Prior cancer of any type for the previous 3 years
• Prior organ, bone marrow, of hematopoietic stem cell transplant
• Contraindication to administration of [18F]FDG
• Inability to undergo a PET/CT scan
• Ongoing infection, either acute or subacute
• Severe COPD or lung disease requiring home oxygen use
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer	24 months	Determine the sensitivity and specificity of liquid biopsy and PET/CT in combination compared with PET/CT alone for predicting lung cancer for lesions 6 mm- 20 mm in size

Secondary Outcome Measures

Name	Time	Method
DNA methylation liquid biopsy ability in detecting lung cancer	24 months	Determine the sensitivity and specificity of DNA methylation liquid biopsy in detecting lung cancer for lesions 6 mm- 20 mm in size
ctDNA gene panel ability in detecting lung cancer	24 months	Determine the sensitivity and specificity of a ctDNA gene panel in detecting lung cancer for lesions 6 mm- 200 mm in size
Validate ML classifier for predicting lung cancer	30 months	Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data.

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States