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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05066776
• Other study ID #: SHANEW_0001
• Status: Terminated
• Start date: September 23, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2023
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ctDNA gene panel ability in detecting lung cancer	Determine the sensitivity and specificity of a ctDNA gene panel in detecting lung cancer for lesions 6 mm- 200 mm in size	24 months
Secondary	DNA methylation liquid biopsy ability in detecting lung cancer	Determine the sensitivity and specificity of DNA methylation liquid biopsy in detecting lung cancer for lesions 6 mm- 20 mm in size	24 months
Secondary	Validate ML classifier for predicting lung cancer	Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data.	30 months