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

NCT05066776 | Terminated

• 1 other identifier: SHANEW_0001
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Keywords

PET-CT Scan; Liquid Biopsies

Outcome Measures

Primary Outcomes (1)

• Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer

  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

  24 months

Secondary Outcomes (3)

• ctDNA gene panel ability in detecting lung cancer

  24 months

• DNA methylation liquid biopsy ability in detecting lung cancer

  24 months

• Validate ML classifier for predicting lung cancer

  30 months

Study Arms (1)

Patients with Pulmonary Nodule

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung nodules found via imaging will be selected from the VA Palo Alto Health Care System.

You may qualify if:

• Over 18 years of age
• ECOG performance status of 0,1, or 2
• Newly discovered lung nodule with:
• At least one solid lung nodule measuring 6 mm- 20 mm in greatest diameter detected on screening CT
• No single lesion larger than 20 mm in greatest diameter when multiple nodules present
• High- or intermediate-risk nodules per American College of Chest Physician (ACCP) guidelines
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (15)

• 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.

  PMID: 31912902 BACKGROUND

• MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.

  PMID: 28240562 BACKGROUND

• Kinsinger LS, Anderson C, Kim J, Larson M, Chan SH, King HA, Rice KL, Slatore CG, Tanner NT, Pittman K, Monte RJ, McNeil RB, Grubber JM, Kelley MJ, Provenzale D, Datta SK, Sperber NS, Barnes LK, Abbott DH, Sims KJ, Whitley RL, Wu RR, Jackson GL. Implementation of Lung Cancer Screening in the Veterans Health Administration. JAMA Intern Med. 2017 Mar 1;177(3):399-406. doi: 10.1001/jamainternmed.2016.9022.

  PMID: 28135352 BACKGROUND

• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

  PMID: 21714641 BACKGROUND

• 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.

  PMID: 30640382 BACKGROUND

• National Comprehensive Cancer Network. NCCN Guidelines Lung Cancer Screening Version 1.2020.

  BACKGROUND

• Li S, Zhao B, Wang X, Yu J, Yan S, Lv C, Yang Y. Overestimated value of (18)F-FDG PET/CT to diagnose pulmonary nodules: Analysis of 298 patients. Clin Radiol. 2014 Aug;69(8):e352-7. doi: 10.1016/j.crad.2014.04.007. Epub 2014 May 27.

  PMID: 24877581 BACKGROUND

• Cescon DW, Bratman SV, Chan SM, Siu LL. Circulating tumor DNA and liquid biopsy in oncology. Nat Cancer. 2020 Mar;1(3):276-290. doi: 10.1038/s43018-020-0043-5. Epub 2020 Mar 20.

  PMID: 35122035 BACKGROUND

• Nair VS, Keu KV, Luttgen MS, Kolatkar A, Vasanawala M, Kuschner W, Bethel K, Iagaru AH, Hoh C, Shrager JB, Loo BW Jr, Bazhenova L, Nieva J, Gambhir SS, Kuhn P. An observational study of circulating tumor cells and (18)F-FDG PET uptake in patients with treatment-naive non-small cell lung cancer. PLoS One. 2013 Jul 5;8(7):e67733. doi: 10.1371/journal.pone.0067733. Print 2013.

  PMID: 23861795 BACKGROUND

• Odahowski CL, Zahnd WE, Eberth JM. Challenges and Opportunities for Lung Cancer Screening in Rural America. J Am Coll Radiol. 2019 Apr;16(4 Pt B):590-595. doi: 10.1016/j.jacr.2019.01.001.

  PMID: 30947892 BACKGROUND

• 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.

  PMID: 31499025 BACKGROUND

• 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.

  PMID: 30777648 BACKGROUND

• 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. doi: 10.1097/MNM.0000000000000605.

  PMID: 27741214 BACKGROUND

• 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.

  PMID: 30882661 BACKGROUND

• Constancio V, Nunes SP, Henrique R, Jeronimo 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):624. doi: 10.3390/cells9030624.

  PMID: 32150897 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rajesh Shah, MD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Radiology

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: September 23, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)