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

Trial ID or NCT#



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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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Rajesh Shah
Rajesh Shah
Interventional radiologist
Clinical Associate Professor, Radiology
Olivier Gevaert
Millie Das
Millie Das
Medical oncologist, Thoracic specialist
Clinical Professor, Medicine - Oncology
Sachin Basiq Malik
Clinical Associate Professor, Radiology
Kristin Jensen

Contact us to find out if this trial is right for you.


Rajesh Shah, MD
650-493-5000 Ext. 65925