Clinical trial · Interventional
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
NCT00537056CI-TRIAL-00028096completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Kidney (Renal Cell) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCE MRI | Procedure | — | UNRESOLVED |
| F-18 Fluoro-deoxi-glucose | Drug | — | UNRESOLVED |
| FDG PET CT | Procedure | — | UNRESOLVED |
| Gadolinium-DTPA | Drug | — | UNRESOLVED |
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- F-18 FDG PET/CT and DCE MRI
- description
- FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
- interventionNames
- Procedure: FDG PET CT
- Procedure: DCE MRI
- Drug: F-18 Fluoro-deoxi-glucose
- Drug: Gadolinium-DTPA
- Drug: Sunitinib
Primary outcomes (1)
- measure
- F-18 FDG Tumor Uptake (SUV Max)
- timeFrame
- 12 weeks minus baseline
- description
- The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:- Measurable disease by RECIST criteria * Pathologic diagnosis of renal cell cancer * Advanced (stage IV) renal cell cancer * Karnofsky performance status of (KPS\>70) * Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan. * Pregnant women. * Healthy volunteers. * Patients participating in other research protocols will be excluded from this study. * Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.
References
Publications (0)
Data not yet available
No reference posted for this study.