NCT07827482Completed
Pretreatment 18F-FDG PET/CT Radiomics for Predicting Response to First-Line Targeted Therapy Plus Immunotherapy in Metastatic Renal Cell Carcinoma
Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) therapy in patients with metastatic renal cell carcinoma. The study reviews existing medical records and imaging data from 228 patients treated at the First Affiliated Hospital of Fujian Medical University between January 2019 and December 2025. Treatment was selected as part of routine clinical care and was not assigned by the study. Imaging features are extracted separately from the primary kidney tumor and metastatic lesions and are then combined to develop a patient-level multi-lesion radiomics model. Treatment response is assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 approximately 12 weeks after treatment initiation. Complete response or partial response is classified as response, whereas stable disease or progressive disease is classified as non-response. The study compares imaging-based, clinical, and combined prediction models and also evaluates their association with progression-free survival.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 228 (actual)
- First submitted
- 7 Sept 2026
- Start date
- 1 Jun 2019
- Primary completion date
- 10 Apr 2026
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Diseases
- Kidney cancer
- NCT number
- NCT07827482
What you commit to
- Study type: Observational
- Participants enrolled: 228
- From 1 Jun 2019 to the primary completion date, 10 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination.
- An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy.
Other
- Unavailable treatment response assessment or follow-up data.
- Incomplete key clinicopathological or imaging information.
- PET/CT image quality inadequate for lesion segmentation or radiomics analysis.
Who the study is looking for
- Pathologically confirmed metastatic renal cell carcinoma.
- Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy.
- Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy.
- At least one measurable lesion according to RECIST version 1.1.
- Available clinicopathological, imaging, treatment response, and follow-up data.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.