Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma

NCT ID: NCT02086734

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Renal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Perfusion-CT

Intervention Type OTHER

1. Baseline Perfusion CT-Scan (before AAT)
2. Follow-Up I Perfusion-CT Scan 7 days after start with AAT
3. Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT

Interventions

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Perfusion-CT

1. Baseline Perfusion CT-Scan (before AAT)
2. Follow-Up I Perfusion-CT Scan 7 days after start with AAT
3. Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jozefina Casuscelli

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Staehler, Prof. Dr. med.

Role: STUDY_CHAIR

Urologische Klinik und Poliklinik der Universität München

Anno Graser, Prof. Dr. med.

Role: STUDY_DIRECTOR

Institut für Klinische Radiologie des Klinikums der Universität München

Alexander Sterzik, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Institut für Klinische Radiologie des Klinikums der Universität München

Jozefina Casuscelli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Urologische Klinik und Poliklinik der Universität München

Locations

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Urologische Klinik und Poliklinik der Universität München

München, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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CTP NK 2012

Identifier Type: -

Identifier Source: org_study_id

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