Trial · NCT07900815
Virtual Follow-up Prediction of Subsolid Pulmonary Nodules: A Prospective Silent Reader Study
NCT07900815, Completed, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Virtual Follow-up Prediction of Subsolid Pulmonary Nodules: A Prospective Silent Reader Study. Trials, record NCT07900815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Virtual Follow-up Prediction of Subsolid Pulmonary Nodules: A Prospective Silent Reader Study
- NCT number
- NCT07900815
- Status
- Completed
- Enrollment
- 200 participants, actual
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Conditions
- Pulmonary Subsolid Nodules, Ground-Glass Nodules
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in radiologists' future nodule growth discrimination (AUC) | Reader assessments are recorded and locked before the corresponding follow-up CT outcome is available; reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | Within-reader difference between no-AI and complete-AI assessments using a prespecified 1-6 growth-likelihood score, compared against actual T2 growth (mass increase \>30% from T1). Unit: AUC difference with 95% CI. |
| Secondary | Simulated management agreement / appropriateness | After the index CT examination and before the corresponding follow-up CT outcome is available at the matched 3-, 6-, or 12-month follow-up window. | Proportion of reader recommendations consistent with independently expert-adjudicated acceptable management reference, compared between modes. Specify whether expert assessment is outcome-blinded or outcome-informed; do not call this objective clinical ground truth. |
| Secondary | Potential under- and over-management | After the index CT examination and before the corresponding follow-up CT outcome is available at the matched 3-, 6-, or 12-month follow-up window. | Proportion of recommendations judged potentially insufficient or excessive; AI-induced favorable and unfavorable decision changes, determined with prespecified blinded review. |
| Secondary | Quantitative growth forecasting | Reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | MAE and relative error of predicted maximal diameter, volume, mass, solid-component maximal diameter, volume/mass growth rate vs true T2. |
| Secondary | Growth classification | Reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | Sensitivity, specificity, F1, accuracy, PPV, NPV and kappa; prespecified mass-growth threshold \>30%. |
| Secondary | Radiologist assessment | Reader assessments are recorded and locked before the corresponding follow-up CT outcome is available; reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | Radiologist performance is evaluated by comparing reader assessments with the corresponding reference outcomes using AUC and accuracy. Prediction of pathological invasiveness is evaluated only in the subgroup with pathologically verified diagnoses. Reader confidence scores and interpretation time are also recorded to characterize assessment confidence and efficiency. |
| Secondary | Generation quality | Reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | The quality of AI-generated follow-up CT images is evaluated against the corresponding actual follow-up CT images at the matched prediction interval. ROI MAE quantifies absolute image-intensity differences. SSIM assesses structural similarity and PSNR assesses image reconstruction fidelity. The Dice similarity coefficient evaluates spatial overlap between the corresponding segmentation masks. Each metric is calculated separately according to its defined measurement scale, and composite image-quality score is calculated. |
| Secondary | Prediction uncertainty | Reference outcomes are assessed using follow-up CT obtained at the matched 3-, 6-, or 12-month follow-up window after the index CT examination. | Prediction uncertainty is evaluated by assessing the calibration and informativeness of AI-generated prediction intervals and their relationship with observed prediction errors. Interval coverage is defined as the proportion of observed follow-up measurements falling within the corresponding predicted intervals. Interval width quantifies the range of each predicted interval. The association between estimated uncertainty and observed prediction error is assessed to determine whether greater predicted uncertainty corresponds to larger prediction errors. |
| Secondary | Image authenticity | After enrollment and before the follow-up CT outcome is available at the matched 3-, 6-, or 12-month follow-up window. | In the independent 100-case ancillary study: source recognition accuracy, synthetic-as-real rate, rating of quality, authenticity, morphological plausibility and clinical usability. |
| Secondary | Incremental-value reader study | After the index CT examination and before the corresponding follow-up CT outcome is available at the matched 3-, 6-, or 12-month follow-up window. | If performed: compare complete AI vs quantitative-only AI, with no-AI baseline; prespecify its primary contrast and sample separately. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900815
GET https://conductscience.org/api/trials/v1/NCT07900815/registered