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

Sponsor
Palo Alto Veterans Institute for Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT05066776
Collaborator
(none)
50
1
27.3
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Liquid Biopsy in Combination With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
    Actual Study Start Date :
    Sep 23, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Pulmonary Nodule

    Patients at high-risk of lung cancer found to have a pulmonary nodule 6-20 mm in size.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. Validate ML classifier for predicting lung cancer [30 months]

      Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Palo Alto Health Care System Palo Alto California United States 94304

    Sponsors and Collaborators

    • Palo Alto Veterans Institute for Research

    Investigators

    • Principal Investigator: Rajesh Shah, MD, VA Palo Alto Health Care System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rajesh Shah, Director of Interventional Radiology, Palo Alto Veterans Institute for Research
    ClinicalTrials.gov Identifier:
    NCT05066776
    Other Study ID Numbers:
    • SHANEW_0001
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rajesh Shah, Director of Interventional Radiology, Palo Alto Veterans Institute for Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2021