Lung NeoplasmNCT06638398
Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules
A study testing Computed Tomography, Diagnostic Procedure and Best Practice in people with Lung Neoplasm, run by Vanderbilt-Ingram Cancer Center at 5 sites in United States.
Trial summary
This clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules [IPNs]). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Computed Tomography, Diagnostic Procedure and Best Practice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Oct 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 35-year-old and older with undiagnosed IPN(s) 8-30mm referred for evaluation
- Referral includes direct in-basket messages in the electronic healthcare record (EHR) to study providers, telehealth visits or clinic visit
- For multiple nodules, we will obtain the score from the dominant or most suspicious nodule based on providers or radiologist impression
- Available CT scan with slice thickness of 3 mm or less with the nodule of interest present. Nodules identified during screening low dose computed tomography of the chest (LDCT) that have had a conventional, follow-up CT performed are eligible for inclusion
Who cannot join
- Pure ground glass nodule
- Patients known to be a prisoners
- Patients known to be pregnant
- Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
- More than 5 IPNs present on imaging
- Nodules referred after initial LDCT for screening with only one LDCT available. The Lung Cancer Prediction Convolutional Neural Network (LCP CNN) algorithm is not currently validated for screening studies
- Thoracic implants that impact the image appearance of the nodule
- Clinician determines that use of the LCP CNN model is required or contraindicated for the optimal care of the patient
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
Meharry Medical College
Nashville, Tennessee, 37208
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, 37212
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
This clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules [IPNs]). The management of IPNs is based on estimating the likelihood that the observed nodule is malignant. Many things, such as age, smoking history, and current symptoms, are considered when making a prediction of the likelihood of malignancy. Radiographic imaging characteristics are also considered. Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign, or potential delays in treatment when results of tests cannot be determined or are falsely negative. The Virtual Nodule Clinic is an artificial intelligence (AI) based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management. The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant. This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays. Using the Virtual Nodule Clinic may work better for the management of IPNs.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone.
II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score.
III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility.
IV. To assess the magnitude of change in patient management with use of the radiomic prediction score.
- To develop a platform that can be used as framework for future larger biomarker studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) computed tomography (CT) evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
ARM II: Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
- Conditions
- Lung Neoplasm
- Being tested
- Computed Tomography, Diagnostic Procedure, Best Practice, Electronic Health Record Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Undergo standard of care Computed Tomography
Diagnostic ProcedureDevice
Receive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software.
Best PracticeOther
Receive standard of care lung nodule management
Electronic Health Record ReviewOther
Ancillary Studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Radiomic Prediction Score) | Experimental | Patients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study. Receives: Procedure: Computed Tomography; Device: Diagnostic Procedure; Other: Best Practice; Other: Electronic Health Record Review |
| Arm II (Usual Care) | Active comparator | Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study. Receives: Procedure: Computed Tomography; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate nodule management
Will be defined as referral for imaging surveillance for ultimately benign nodules, and biopsy, positron emission tomography scan, surgery or empiric stereotactic body radiation therapy for malignant nodules. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will compare the proportion with appropriate management across the two arms using a two-sided Z-test of proportions with pooled variances.
Measured: Up to 1 Year
Secondary outcomes (3)
Change in management
Change in management Will be based on intervention probability curve (IPC) assessment. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will fit an intervention probability curve to both arms independently, using the method described by Kammer et al., by using the bootstrap-resample-with-dither approach. Then, will test the hypothesis that the slope of the IPC in the intervention arm is different from the slope of the IPC in the control arm by using the analysis of covariance, with a significance level of 0.05.
Measured: Up to 2 years
Unnecessary invasive procedures
Unnecessary invasive procedures Will be defined as: 1) invasive procedure with definite benign findings on biopsy or 2) non-diagnostic findings on biopsy but stable follow up imaging, evaluated over two years of follow-up. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Any invasive procedures will be compared across arms using a two-sided Z-test with pooled variances.
Measured: Up to 2 years
Time to diagnosis in patients with malignant nodules
Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will be compared across arms using a logrank test
Measured: From the time of expert provider evaluation to the time of final diagnosis in days, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Oct 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638398
- Sponsor's protocol ID
- VICC-IDTHO24059
- Other IDs
- 5R01CA252964-02, NCI-2024-08453
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Paez R, Khalil TA, Forero Y, Woodhouse P, Antic S, Holmes H, Fremont RD, Brandt W, Chen H, Chen SC, Kaizer A, Shojaee S, Lentz RJ, Deppen SA, Baron AE, Grogan EL, Maldonado F. Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized trial. Trials. 2026 May 12;27(1):467. doi: 10.1186/s13063-026-09727-y.
PubMed 42121244
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Biomarker Platform for Stratifying Indeterminate Pulmonary Nodules - The SPOT IT Platform Trial
- ClinicalTrials.gov ID
- NCT06638398
- Acronym / sponsor ID
- VICC-IDTHO24059
- Conditions
- Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies whether a biomarker platform, the Virtual Nodule Clinic, can be used for the management of lung (pulmonary) nodules that are not clearly non-cancerous (benign) or clearly cancerous (malignant) (indeterminate pulmonary nodules [IPNs]). The management of IPNs is based on estimating the likelihood that the observed nodule is malignant. Many things, such as age, smoking history, and current symptoms, are considered when making a prediction of the likelihood of malignancy. Radiographic imaging characteristics are also considered. Lung nodule management for IPNs can result in unnecessary invasive procedures for nodules that are ultimately determined to be benign, or potential delays in treatment when results of tests cannot be determined or are falsely negative. The Virtual Nodule Clinic is an artificial intelligence (AI) based imaging software within the electronic health record which makes certain that identified pulmonary nodules are screened by clinicians with expertise in nodule management. The Virtual Nodule Clinic also features an AI based radiomic prediction score which designates the likelihood that a pulmonary nodule is malignant. This may improve the ability to manage IPNs and lower unnecessary invasive procedures or treatment delays. Using the Virtual Nodule Clinic may work better for the management of IPNs.
Detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone.
II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score.
III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility.
IV. To assess the magnitude of change in patient management with use of the radiomic prediction score.
- To develop a platform that can be used as framework for future larger biomarker studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) computed tomography (CT) evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.
ARM II: Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Radiomic Prediction Score) | Experimental | Procedure: Computed Tomography, Device: Diagnostic Procedure, Other: Best Practice, Other: Electronic Health Record ReviewPatients undergo SOC CT evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study. |
| Arm II (Usual Care) | Active comparator | Procedure: Computed Tomography, Other: Best PracticePatients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 35-year-old and older with undiagnosed IPN(s) 8-30mm referred for evaluation
- Available CT scan with slice thickness of 3 mm or less with the nodule of interest present. Nodules identified during screening low dose computed tomography of the chest (LDCT) that have had a conventional, follow-up CT performed are eligible for inclusion
Key exclusion criteria (8 listed)
- Pure ground glass nodule
- Patients known to be a prisoners
- Patients known to be pregnant
- Known active malignancy within the last 5 years at time of enrollment (excluding non-melanoma skin cancers)
- More than 5 IPNs present on imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyUndergo standard of care Computed Tomography | Procedure or surgery | Arm I (Radiomic Prediction Score), Arm II (Usual Care) |
| Diagnostic ProcedureReceive a Virtual Nodule Clinic radiomic prediction score obtained in Optellum software. | Device | Arm I (Radiomic Prediction Score) |
| Best PracticeReceive standard of care lung nodule management | Other | Arm I (Radiomic Prediction Score), Arm II (Usual Care) |
| Electronic Health Record ReviewAncillary Studies | Other | Arm I (Radiomic Prediction Score) |
Primary outcome
Appropriate nodule management
Time frame: Up to 1 Year
Will be defined as referral for imaging surveillance for ultimately benign nodules, and biopsy, positron emission tomography scan, surgery or empiric stereotactic body radiation therapy for malignant nodules. Standard consort diagram will be created. Descriptive statistics including means, standard deviations, and median and interquartile ranges for continuous parameters, as well as percentages and frequencies for categorical parameters will be presented. Will compare the proportion with appropriate management across the two arms using a two-sided Z-test of proportions with pooled variances.
3 secondary outcomes
Change in management
Time frame: Up to 2 years
Unnecessary invasive procedures
Time frame: Up to 2 years
Time to diagnosis in patients with malignant nodules
Time frame: From the time of expert provider evaluation to the time of final diagnosis in days, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42121244Paez R, Khalil TA, Forero Y, Woodhouse P, Antic S, Holmes H, Fremont RD, Brandt W, Chen H, Chen SC, Kaizer A, Shojaee S, Lentz RJ, Deppen SA, Baron AE, Grogan EL, Maldonado F. Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized trial. Trials. 2026 May 12;27(1):467. doi: 10.1186/s13063-026-09727-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Maldonado, MD principal investigator
Vanderbilt University/Ingram Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Diagnostic Procedure and Best Practice in people with Lung Neoplasm, run by Vanderbilt-Ingram Cancer Center at 5 sites 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Appropriate nodule management (time frame: Up to 1 Year). 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 NCT06638398, which also lists 1 linked publication.
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 27 Mar 2026.