Clinical trial · Observational
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
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib Plus Pembrolizumab or Toripalimab | Drug | — | UNRESOLVED |
| Pretreatment 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic Renal Cell Carcinoma Cohort
- description
- Patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study.
- interventionNames
- Diagnostic Test: Pretreatment 18F-FDG PET/CT
- Drug: Axitinib Plus Pembrolizumab or Toripalimab
Primary outcomes (1)
- measure
- Treatment Response According to RECIST Version 1.1
- timeFrame
- At 12 weeks after initiation of first-line TKI plus ICI therapy
- description
- Number and percentage of participants categorized as having complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed metastatic renal cell carcinoma. 2. Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy. 3. Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy. 4. At least one measurable lesion according to RECIST version 1.1. 5. Available clinicopathological, imaging, treatment response, and follow-up data. Exclusion Criteria: 1. Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination. 2. An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy. 3. Unavailable treatment response assessment or follow-up data. 4. Incomplete key clinicopathological or imaging information. 5. PET/CT image quality inadequate for lesion segmentation or radiomics analysis.
References
Publications (0)
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