Health TrialsbyHealthPanel

Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES

ConditionsLung CancerPulmonary Nodule, Solitary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-89
SponsorAbramson Cancer Center at Penn Medicine

About this trial

This is a pragmatic clinical trial that will study the effect of a radiomics-based computer-aided diagnosis (CAD) tool on clinicians' management of pulmonary nodules (PNs) compared to usual care. Adults aged 35-89 years with 8-30mm PNs evaluated at Penn Medicine PN clinics will undergo 1:1 randomization to one of two groups, defined by the PN malignancy risk stratification strategy used by evaluating clinicians: 1) usual care or 2) usual care + use of a radiomics-based CAD tool.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 35-89 years

Scheduled to be evaluated at a UPHS PN clinic

Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit

Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software

Disqualifiers

Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (>10mm in maximal short-axis diameter on axial CT images)

PNs with popcorn calcification (consistent with benign etiology)

Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy)

PN previously seen on CT imaging >60 days prior to most recent CT

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optellum Virtual Nodule Clinic

    Device

    The Optellum Virtual Nodule Clinic is an FDA-approved (Class II) device for risk stratification of pulmonary nodules. It uses a convolutional neural network to evaluate CT imaging data to provide an estimate of malignancy risk for indeterminate pulmonary nodules.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Usual care (clinician assessment)No intervention 0 interventions
Group B: Clinician assessment + CAD-based risk stratificationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Appropriate management of pulmonary nodule

The composite proportion of benign pulmonary nodules managed with imaging surveillance and malignant pulmonary nodules managed with biopsy or empiric treatment. Final pulmonary nodule diagnosis will be categorized as malignant or benign based on pathologic evaluation. If pathology is unavailable or inconclusive (i.e., the biopsy was non-diagnostic), pulmonary nodule resolution, shrinkage, or diameter stability at 12 months will be defined as a benign diagnosis.

Time frame
12 months

Secondary outcomes

1

Timeliness of care

For patients with malignant pulmonary nodules, defined as the number of days between the index clinic visit and diagnosis of malignancy and receipt of treatment for malignancy (i.e., surgical resection, radiation therapy).

Time frame
12 months
2

Adverse events

For patients undergoing biopsy, defined as procedural complications related to pulmonary nodule biopsy.

Time frame
12 months
3

Diagnostic yield

Using information found in pathology reports, defined as the proportion of biopsies with a definitive histopathologic diagnosis, for each type of diagnostic biopsy procedure.

Time frame
12 months
4

Healthcare costs

The costs of all imaging studies and diagnostic testing associated with the pulmonary nodule diagnostic process, based on Medicare allowed amounts (amount paid by Medicare and the amount paid by the beneficiary and/or third parties).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
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