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Clinical Trials in China / NCT07901569
Starting soon Observational

Habitat Analysis of Tumor Thrombus for Vena Cava Wall Invasion in Renal Cell Carcinoma

NCT07901569 · tracked via the Priya Life Science China tracker
Sponsor
Liu Zhuo
Phase
Observational
Started
2026-11-30
Last updated
2026-10-28

Condition(s) studied

Carcinoma, Renal CellInferior Vena Cava Tumor Thrombus

Study summary

Tumor thrombus in the inferior vena cava can invade the vessel wall. Doctors must know the invasion status before surgery. The status changes the surgical plan. Preoperative imaging has limited accuracy for wall invasion. Habitat imaging divides a tumor into subregions. Each subregion is a habitat. The method uses voxel-level image features.

This study will test whether habitat imaging can diagnose inferior vena cava wall invasion. The participants have renal cell carcinoma with renal vein or inferior vena cava tumor thrombus. The study will use existing preoperative contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) images. The reference standard is the pathology report from surgery.

The primary measurement is the area under the receiver operating characteristic curve (AUROC) of the habitat model for wall invasion. The study will also measure sensitivity, specificity, calibration, and clinical utility. In an exploratory analysis, the study will compare imaging habitats with spatial transcriptomic regions. The study will use available Visium data from two participants.

This is a retrospective observational study. The study has no intervention. The study will not change clinical care. The results will show whether habitat imaging can support preoperative planning.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * The participant is 18 years or older at surgery. * The participant had radical nephrectomy with tumor thrombectomy at the study center. * The participant had renal cell carcinoma with renal vein or inferior vena cava tumor thrombus. * The pathology report confirms renal cell carcinoma. Any histological subtype is eligible. * The participant has a preoperative contrast-enhanced computed tomography (CT) or MRI image. The CT/MRI phase is complete. The image has no severe artifact that prevents segmentation. * The participant has a surgical pathology report. The report states the inferior vena cava wall invasion status. Exclusion Criteria: * The pathology report shows a non-renal-cell-carcinoma histology. Examples are urothelial carcinoma, renal pelvic carcinoma, angiomyolipoma, and adrenocortical carcinoma. * The preoperative contrast-enhanced CT/MRI image is missing or not adequate. Examples are no contrast phase, severe artifact, or no segmentable image. * The surgical pathology report is missing. The report does not state the wall invasion status. * The reader cannot delineate the tumor thrombus on the image. The study team will report this case as an independent failure reason. The team will not merge this case with missing data.

Primary outcome measure(s)

  • Diagnostic Performance (AUROC) of Preoperative CT/MRI Habitat Imaging for Inferior Vena Cava Wall Invasion — within 8 weeks after the surgery
    The study team will measure the diagnostic performance of a habitat imaging model. The model uses preoperative contrast-enhanced CT and MRI. The target condition is inferior vena cava wall invasion. The reference standard is the structured pathology report from surgery. The primary metric is the area under the receiver operating characteristic curve (AUROC) with the 95% confidence interval. The team will also report sensitivity and specificity at a pre-specified threshold. The team will use nested cross-validation and bootstrap for internal validation. Calibration and clinical utility are secondary endpoints.

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901569 on ClinicalTrials.gov ↗ ← All trials in China