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

Palo Alto Veterans Institute for Research

Status: Terminated

Conditions: Solitary Pulmonary Nodule; Lung Cancer; Multiple Pulmonary Nodules

Study type: Observational

Funder types: Other

Identifiers

NCT05066776

SHANEW_0001

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 1 patient group

Patients with Pulmonary Nodule

Description:

Patients at high-risk of lung cancer found to have a pulmonary nodule 6-20 mm in size.