Sunitinib Treatment on Tissue Sodium Accumulation (TSS2)
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|ClinicalTrials.gov Identifier: NCT04368546|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment|
|Renal Cell Cancer Metastatic Hypertension Sodium Imbalance||Drug: Sunitinib|
Tyrosine kinases-inhibitors targeting vascular endothelial growth factor (VEGF)-receptors (RTKIs) are increasingly used in oncology in several metastatic tumor types. These agents are featured by toxicities including hypertension. According to a new insight, sodium in response to a high dietary sodium intake, is accumulated in a hyperosmolar way in the interstitial compartment. In response to this high sodium concentration cells of the mononuclear phagocytic system (MPS) are activated resulting in an increased production of VEGF-C, activation of VEGF type 3 receptors and formation of a lymphatic capillary network, involved in clearance of interstitial sodium. Blockade of stimulation of VEGF-C receptors or depletion of MPS cells in rodents has been associated with salt-sensitive hypertension.
Sunitinib is an orally-active, multitarget RTKI mainly used for the treatment of patients with metastatic renal cancer and imatinib-resistant gastrointestinal stromal tumors. Sunitinib blocks all three VEGF receptors subtypes, including VEGF-receptor type 3.
The investigators hypothesize that treatment of patients with sunitinib is associated with tissue sodium accumulation and this accumulation contributes to the rise in blood pressure. Tissue sodium is measured by using a newly developed 23Na magnetic resonance-imaging (MRI) technique which allows a non-invasive and contrast agent-free sodium content measurement in the muscle and skin of the lower leg.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Effect of Sunitinib Treatment on Tissue Sodium Accumulation in Patients With Renal Cancer: a Pilot Study|
|Actual Study Start Date :||November 1, 2015|
|Actual Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
Metastatic cell carcinoma patients before sunitinib treatment, after 4 week on, after 2 week off and finally again 4 week on medication.
Other Name: Diagnostic test: 23Na-MRI
Age-matched subjects without known disease.
- Skin sodium [ Time Frame: 3 months (before, 4 weeks on, 2 weeks off and 4 weeks on medication) ]Changes in sodium content measured by 23Na magnetic resonance-imaging (MRI) technique
- Plasma VEGF-C [ Time Frame: 3 months (before, 4 weeks on, 2 weeks off and 4 weeks on medication) ]Concentration of VEGF-C in patients plasma
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368546
|Experimental and Clinical Research Center, Clinical Research Unit|
|Berlin, Germany, 13125|
|Study Director:||Dominik Müller, PhD||Group leader at the Max Delbruck Center for Molecular Medicine|