Metastatic Renal CancerNCT02086734
Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
An observational study of Metastatic Renal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cancer
- What is being tested?
- Perfusion-CT
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Urologische Klinik und Poliklinik der Universität München
München, Bavaria, 81377
About this study
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
- Being tested
- Perfusion-CT
- Keywords
- Perfusion-CT, mRCC, antiangiogenic therapy, response assessment
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion-CTOther
- Baseline Perfusion CT-Scan (before AAT)
- Follow-Up I Perfusion-CT Scan 7 days after start with AAT
- Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Perfusion-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters
Measured: 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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jozefina Casuscelli, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Staehler, Prof. Dr. med., Study chair, Urologische Klinik und Poliklinik der Universität MünchenAnno Graser, Prof. Dr. med., Study director, Institut für Klinische Radiologie des Klinikums der Universität MünchenAlexander Sterzik, Dr. med., Principal investigator, Institut für Klinische Radiologie des Klinikums der Universität MünchenJozefina Casuscelli, Dr. med., Principal investigator, Urologische Klinik und Poliklinik der Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086734
- Sponsor's protocol ID
- CTP NK 2012
- Status last verified
- Sep 2018
- First submitted
- 28 Nov 2013
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02086734
- Acronym / sponsor ID
- CTP NK 2012
- Conditions
- Metastatic Renal Cancer
- Keywords
- Perfusion-CT, mRCC, antiangiogenic therapy, response assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRCC patients assessed with Perfusion CT | – | Other: Perfusion-CTStudy population consists of patients with metastasized renal cancer eligible for AAT with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) evaluated with Perfusion-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- not given informed consent
- known iodine allergy
- high grade renal insuffiency (eGFR < 30ml/min) not on dialysis
- overt hyperthyreoidism
- singular metastases <1cm in diameter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfusion-CT1. 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 | Other | mRCC patients assessed with Perfusion CT |
Primary outcome
Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters
Time frame: up to 3 years
1 secondary outcome
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
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Staehler, Prof. Dr. med. study chair
Urologische Klinik und Poliklinik der Universität München
Anno Graser, Prof. Dr. med. study director
Institut für Klinische Radiologie des Klinikums der Universität München
Alexander Sterzik, Dr. med. principal investigator
Institut für Klinische Radiologie des Klinikums der Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.