Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT
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|ClinicalTrials.gov Identifier: NCT03616951|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
The incidence of renal cancer in Denmark is approximately 900 new cases per year. Untreated, the 5-year survival rate for metastatic renal cancer (mRCC) is 2%. Development of angiogenesis inhibitors (AI) and check-point immunotherapy (CPI) has improved survival.
Treatment efficacy is evaluated by CT scans, using RESIST 1.1 (Response Evaluation Criteria in Solid Tumors). However, progressin in patients with mRCC treated with AI or CPI is difficult to characterize at the right time, using the RECIST 1.1. Therefore approximately 50 % of the patients are 'lost' to further treatment at the time of progression and die.
The investigators aim to evaluate if functional imaging parameters using spectral CT-techniques can detect treatment failure earlier, or more accurate, than routine CT. This could help us develop a new set of response evaluation criteria for functional imaging, giving a more precise assessment of treatment effect in patients with mRCC treated with AI and CPI.
|Condition or disease|
|Renal Neoplasm With Metastasis Response Evaluation Criteria in Solid Tumors|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Response Evaluation Criteria in Metastatic Renal Cell Carcinoma: Improved Assessment of Response and Progression by Spectral-CT|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
- Progression-free survival (PFS) [ Time Frame: PFS is the time from the initiation of therapy and until progressive disease or death, whichever comes first - assessed up to 60 months. If a patient does not progress, PFS will be censored at the time of last follow-up - assessed up to 60 months. ]PFS is the time from the initiation of therapy and until progressive disease or death, whichever comes first, assessed up to 60 months. If a patient does not progress, PFS will be censored at the time of last follow-up - assessed up to 60 months.
- overall survival [ Time Frame: Overall survival is the time between the first day of treatment and the date of death or last follow-up - assessed up to 60 months. ]Overall survival is the time between the first day of treatment and the date of death or last follow-up - assessed up to 60 months.
- Best response [ Time Frame: Time from inclusion to best response - assessed up to 60 months. ]Response will be categorized according to the criteria from RECIST 1.1: complete response, partial response, stable disease and progressive disease - assessed up to 60 months.
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): NCT03616951
|Contact: Frede Donskov, MD, DMSc, associate professor||+ 45 firstname.lastname@example.org|
|Contact: Aska Drljevic-Nielsen, MD, ph.d-student||+45 email@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000/8200|
|Contact: aska drljevic-nielsen, MD, ph.d-student 28490381 firstname.lastname@example.org|
|Principal Investigator: Frede Donskov, MD, DMSc, Associate Professor|
|Principal Investigator:||Frede Donskov, MD, DMSc||Department of oncology, Aarhus Universety Hospital|