Radiomics Tool for Pulmonary Nodule Risk Stratification

  • STATUS
    Recruiting
  • participants needed
    300
Send
Updated on 11 July 2024

Summary

The objective of this pragmatic clinical trial is to determine the real-world effect of a radiomics-based computer-aided diagnosis tool on pulmonary nodule management decisions. We hypothesize that a higher proportion of pulmonary nodules will be appropriately managed when clinicians prospectively use a CAD-based risk stratification strategy to evaluate pulmonary nodules. The primary outcome variable is appropriate pulmonary nodule management at the index clinic visit, defined as the composite proportion of benign pulmonary nodules managed with surveillance and malignant pulmonary nodules managed with biopsy or empiric treatment. Final pulmonary nodule diagnosis will be categorized as malignant or benign. If the pathology report does not offer a specific pathologic diagnosis or is inconclusive (i.e., the biopsy was non-diagnostic), we will define pulmonary nodule resolution, shrinkage, or diameter stability at 12 months as a benign diagnosis. Secondary outcome variables will include measures of quality (timeliness), harms (adverse events), diagnostic yield, and healthcare costs.

Details
Condition Medical Research
Age 99years or below
Clinical Study IdentifierTX15116
Last Modified on11 July 2024

Eligibility

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.