Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with Pulmonary Nodule Patients at high-risk of lung cancer found to have a pulmonary nodule 6-20 mm in size. |
Outcome Measures
Primary Outcome Measures
- Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer [24 months]
Determine the sensitivity and specificity of liquid biopsy and PET/CT in combination compared with PET/CT alone for predicting lung cancer for lesions 6 mm- 20 mm in size
Secondary Outcome Measures
- ctDNA gene panel ability in detecting lung cancer [24 months]
Determine the sensitivity and specificity of a ctDNA gene panel in detecting lung cancer for lesions 6 mm- 200 mm in size
- DNA methylation liquid biopsy ability in detecting lung cancer [24 months]
Determine the sensitivity and specificity of DNA methylation liquid biopsy in detecting lung cancer for lesions 6 mm- 20 mm in size
- Validate ML classifier for predicting lung cancer [30 months]
Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 18 years of age
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ECOG performance status of 0,1, or 2
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Newly discovered lung nodule with:
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At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT
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No single lesion larger than 20 mm in greatest diameter when multiple nodules present
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High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines
- Able to provide informed consent
Exclusion Criteria:
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Prior cancer of any type for the previous 3 years
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Prior organ, bone marrow, of hematopoietic stem cell transplant
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Contraindication to administration of [18F]FDG
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Inability to undergo a PET/CT scan
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Ongoing infection, either acute or subacute
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Severe COPD or lung disease requiring home oxygen use
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Pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94304 |
Sponsors and Collaborators
- Palo Alto Veterans Institute for Research
Investigators
- Principal Investigator: Rajesh Shah, MD, VA Palo Alto Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
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- Constâncio V, Nunes SP, Henrique R, Jerónimo C. DNA Methylation-Based Testing in Liquid Biopsies as Detection and Prognostic Biomarkers for the Four Major Cancer Types. Cells. 2020 Mar 5;9(3). pii: E624. doi: 10.3390/cells9030624. Review.
- Huo J, Xu Y, Sheu T, Volk RJ, Shih YT. Complication Rates and Downstream Medical Costs Associated With Invasive Diagnostic Procedures for Lung Abnormalities in the Community Setting. JAMA Intern Med. 2019 Mar 1;179(3):324-332. doi: 10.1001/jamainternmed.2018.6277.
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- National Comprehensive Cancer Network. NCCN Guidelines Lung Cancer Screening Version 1.2020.
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- Ruilong Z, Daohai X, Li G, Xiaohong W, Chunjie W, Lei T. Diagnostic value of 18F-FDG-PET/CT for the evaluation of solitary pulmonary nodules: a systematic review and meta-analysis. Nucl Med Commun. 2017 Jan;38(1):67-75. Review.
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Spalluto LB, Lewis JA, LaBaze S, Sandler KL, Paulson AB, Callaway-Lane C, Grogan EL, Massion PP, Roumie CL. Association of a Lung Screening Program Coordinator With Adherence to Annual CT Lung Screening at a Large Academic Institution. J Am Coll Radiol. 2020 Feb;17(2):208-215. doi: 10.1016/j.jacr.2019.08.010. Epub 2019 Sep 6.
- Tang K, Wang L, Lin J, Zheng X, Wu Y. The value of 18F-FDG PET/CT in the diagnosis of different size of solitary pulmonary nodules. Medicine (Baltimore). 2019 Mar;98(11):e14813. doi: 10.1097/MD.0000000000014813.
- Triplette M, Thayer JH, Pipavath SN, Crothers K. Poor Uptake of Lung Cancer Screening: Opportunities for Improvement. J Am Coll Radiol. 2019 Apr;16(4 Pt A):446-450. doi: 10.1016/j.jacr.2018.12.018. Epub 2019 Feb 15. Review.
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