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

Trial ID or NCT#

NCT05066776

Status

not recruiting iconNOT RECRUITING

Purpose

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. 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

Investigator(s)

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
Kristin Jensen
Pathologist, Cytopathologist, Immunodiagnosis pathologist, Surgical pathologist
Associate Professor of Pathology at the Palo Alto Veteran's Health Care System and at Stanford University Medical Center

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

Contact

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