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


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Trial ID: NCT05066776


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

Stanford Investigator(s)

Rajesh Shah
Rajesh Shah

Clinical Associate Professor, Radiology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

Sachin Basiq Malik

Clinical Associate Professor, Radiology


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

      3. High- or intermediate-risk nodules per American College of Chest Physician (ACCP)

   - 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


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rajesh Shah, MD
650-493-5000 Ext. 65925