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

NCT02086734 | Completed

• 1 other identifier: CTP NK 2012
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Renal Cancer

Keywords

Perfusion-CT; mRCC; antiangiogenic therapy; response assessment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Other: Perfusion-CT

Interventions

Perfusion-CT 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

mRCC patients assessed with Perfusion CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)
• with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as first-line therapy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Urologische Klinik und Poliklinik der Universität München

München, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: March 13, 2014
• Study Start: April 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

DE (1)