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AzTrials

Lung CancerNCT05066776

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

An observational study of Lung Cancer and Solitary Pulmonary Nodule, run by Palo Alto Veterans Institute for Research at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
31 participants
Where
1 siteUnited States
Study dates
23 Sep 2021to 1 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

Other trials in United States

About this study

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

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.

Keywords
PET-CT Scan, Liquid Biopsies
Medical subject headings
Lung Neoplasms, Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05066776
Study groupRoleWhat they receive
Patients with Pulmonary NodulePatients at high-risk of lung cancer found to have a pulmonary nodule 6-20 mm in size.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (3)

  1. 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

    Measured: 24 months

  2. 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

    Measured: 24 months

  3. Validate ML classifier for predicting lung cancer

    Validate a machine learning (ML) classifier for predicting lung cancer using imaging and clinical data.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start23 Sep 2021
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Why it stopped: Withdrawal by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066776
Sponsor's protocol ID
SHANEW_0001
Status last verified
Dec 2023
First submitted
23 Sep 2021
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31912902

  • 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.

    PubMed 28240562

  • 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.

    PubMed 28135352

  • 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.

    PubMed 21714641

  • 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.

    PubMed 30640382

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

  • 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.

    PubMed 24877581

  • 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.

    PubMed 35122035

  • 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.

    PubMed 23861795

  • 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.

    PubMed 30947892

  • 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.

    PubMed 31499025

  • 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.

    PubMed 30777648

  • 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.

    PubMed 27741214

  • 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.

    PubMed 30882661

  • 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.

    PubMed 32150897

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Solitary Pulmonary Nodule, run by Palo Alto Veterans Institute for Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Withdrawal by sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of liquid biopsy with PET/CT to PET/CT alone for predicting lung cancer (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05066776, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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