Clinical trial NCT05066776: Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
Official title: Liquid Biopsy in Combination With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Keywords: PET-CT Scan
Liquid Biopsies
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung nodules found via imaging will be selected from the VA Palo Alto Health Care System.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer
timeFrame: 24 months
Secondary outcomes:
measure: ctDNA gene panel ability in detecting lung cancer
timeFrame: 24 months
measure: DNA methylation liquid biopsy ability in detecting lung cancer
timeFrame: 24 months
measure: Validate ML classifier for predicting lung cancer
timeFrame: 30 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Rajesh Shah, MD
role: PRINCIPAL_INVESTIGATOR
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