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A new MRI approach could spare patients unnecessary lung biopsies

NCT ID NCT07768046

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study explores whether a special MRI scan, done without any contrast dye, can tell the difference between benign and cancerous lung nodules that were flagged as suspicious on a routine lung cancer screening CT. Adults aged 50 to 80 with a history of heavy smoking and a Lung-RADS 4 nodule will receive one additional MRI scan. The MRI results will be compared with the final diagnosis from biopsy or long-term follow-up to see how accurate the scan is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multiparametric chest MRI with diffusion-weighted imaging (no contrast)
What this could lead to
If successful, this could offer a safer, contrast-free imaging method to help doctors decide which lung nodules need biopsy, reducing unnecessary invasive procedures.
What could go wrong
This is a small pilot study with only 30 participants, so results may not be definitive. The MRI might not reliably distinguish all benign from malignant nodules, and its accuracy needs confirmation in larger trials.

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.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Adults aged 50 to 80 years enrolled in the University of Florida lung cancer screening program who meet 2021 USPSTF screening eligibility (at least a 20 pack-year smoking history, currently smoking or quit within the past 15 years) and whose standard-of-care screening low-dose chest CT was assigned Lung-RADS category 4 (4A, 4B, or 4X). Participants are identified consecutively from institutional lung cancer screening CT reports and approached through a treating clinician who is a listed investigator, or through the UF Consent2Share registry.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 50 to 80 years, inclusive. 2. At least a 20 pack-year cigarette smoking history, and currently smoking or quit within the past 15 years (2021 USPSTF lung cancer screening eligibility). 3. Underwent a standard-of-care lung cancer screening low-dose chest CT (LDCT) at the University of Florida that was assigned Lung-RADS category 4 (4A, 4B, or 4X) per ACR Lung-RADS v2022. 4. Able to provide written informed consent independently. Exclusion Criteria: 1. Part-solid or cystic nodule with a solid component measuring less than 8 mm. 2. Endobronchial nodule. 3. MRI-incompatible or potentially MRI-incompatible implanted device. 4. Claustrophobia that would prevent the participant from tolerating the MRI examination. 5. Metallic device in the chest wall or spine that may interfere with adequate image acquisition in the field of view (assessed case by case). 6. History of prior lung resection for a benign condition that may create susceptibility artifact in the field of view. 7. Home oxygen supplementation. 8. Active or treated lower respiratory tract infection within the prior 4 weeks. 9. Lack of capacity to consent.

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Conditions

The condition(s) this trial relates to.

lung neoplasm Multiple Pulmonary Nodules pulmonary coin lesion

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

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