Clinical trial NCT02086734: Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
Official title: Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cancer
Keywords: Perfusion-CT
mRCC
antiangiogenic therapy
response assessment
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)

  1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as first-line therapy
  2. with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as second-line therapy after failed first-line therapy, who are off therapy for at least 2 weeks
* no contraindications against contrast-enhanced CT
* obtained informed consent to participate in the study

Exclusion Criteria:

Patients who have:

* not given informed consent
* known iodine allergy
* high grade renal insuffiency (eGFR \< 30ml/min) not on dialysis
* overt hyperthyreoidism
* singular metastases \<1cm in diameter
* an increase of their baseline creatine levels of \>20% between CT examinations

Primary outcomes:
measure: Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters
timeFrame: up to 3 years
Secondary outcomes:
measure: 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
timeFrame: up to 3 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Urologische Klinik und Poliklinik der Universität München
state: Bavaria
Study officials:
affiliation: Urologische Klinik und Poliklinik der Universität München
name: Michael Staehler, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: Institut für Klinische Radiologie des Klinikums der Universität München
name: Anno Graser, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Institut für Klinische Radiologie des Klinikums der Universität München
name: Alexander Sterzik, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Urologische Klinik und Poliklinik der Universität München
name: Jozefina Casuscelli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: