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TerminatedNot applicableNCT05066776
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLung Cancer · Solitary Pulmonary Nodule

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 8, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Palo Alto Veterans Institute for Research

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Palo Alto Veterans Institute for Research
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • VA Palo Alto Health Care SystemPalo Alto, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 8, 2023. Always confirm current availability with the study team.

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