AI could help doctors spot lung cancer earlier, avoid unnecessary biopsies
NCT ID NCT05968898
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an FDA-approved AI software that analyzes CT scans of lung nodules to estimate cancer risk. 300 adults aged 35-89 with newly found lung nodules will be randomly assigned to have their doctors use the AI tool or not. The goal is to see if the AI helps doctors manage nodules more appropriately—recommending monitoring for benign ones and prompt action for cancerous ones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Optellum Virtual Nodule Clinic (AI software device)
- What this could lead to
- If successful, this AI tool could help doctors more accurately identify which lung nodules are cancerous, leading to faster treatment for cancer and fewer unnecessary biopsies for benign nodules.
- What could go wrong
- This is a relatively small, early-stage trial (300 participants) testing a device already FDA-approved. The AI may not improve outcomes in all settings, and its effectiveness depends on how doctors use it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, aged 35-89 years 2. Scheduled to be evaluated at a UPHS PN clinic 3. Newly discovered solid or part-solid indeterminate PN 8-30mm in maximal diameter on CT imaging within 60 days of index clinic visit 4. Chest CT imaging meeting the technical requirements for compatibility with Optellum Virtual Nodule Clinic software Exclusion Criteria: 1. Chest CT imaging with discrete mediastinal or hilar lymphadenopathy by CT size criteria (\>10mm in maximal short-axis diameter on axial CT images) 2. PNs with popcorn calcification (consistent with benign etiology) 3. Pure ground-glass subsolid PNs (may be associated with lower risk of clinically significant malignancy) 4. PN previously seen on CT imaging \>60 days prior to most recent CT 5. More than one indeterminate PN 8-30mm in maximal diameter 6. History of lung cancer 7. History of active cancer within the previous 5 years 8. Presence of a thoracic implant that impedes PN visualization
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Penn Medicine University City
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Penn Medicine Washington Square
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Perelman Center for Advanced Medicine
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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