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)

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

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

Contact

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