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The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT) for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC) undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.
In this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT. Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions will be quantified and correlated with patient outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRCC patients assessed with Perfusion CT | Study population consists of patients with metastasized renal cancer eligible for AAT with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) evaluated with Perfusion-CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfusion-CT | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1 | up to 3 years |
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Inclusion Criteria:
patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)
no contraindications against contrast-enhanced CT
obtained informed consent to participate in the study
Exclusion Criteria:
Patients who have:
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Patients with metastatic renal cell cancer eligible for AAT (antiangiogenic therapy) with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) presenting at the Departement of Urology. LMU, meeting the inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Staehler, Prof. Dr. med. | Urologische Klinik und Poliklinik der Universität München | Study Chair |
| Anno Graser, Prof. Dr. med. | Institut für Klinische Radiologie des Klinikums der Universität München | Study Director |
| Alexander Sterzik, Dr. med. | Institut für Klinische Radiologie des Klinikums der Universität München | Principal Investigator |
| Jozefina Casuscelli, Dr. med. | Urologische Klinik und Poliklinik der Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologische Klinik und Poliklinik der Universität München | München | Bavaria | 81377 | Germany |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003570 | Cytidine Triphosphate |
| ID | Term |
|---|---|
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006571 |
| Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |