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NCT03616951

Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT

Status unknown Last updated 24 April 2020
What this trial tests

trial in Renal Neoplasm With Metastasis in 60 participants. Status unknown.

Timeline
1 January 2018
Primary endpoint
1 January 2023
1 January 2024

Quick facts

Lead sponsorUniversity of Aarhus
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment60
Start date1 January 2018
Primary completion1 January 2023
Estimated completion1 January 2024
Sites1 location across Denmark

Conditions studied

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Renal Neoplasm With Metastasis or Response Evaluation Criteria in Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prognostic Utility of Parameters Derived From Pretreatment Dual-Layer Spectral-Detector CT in Patients With Metastatic Renal Cell Carcinoma.
    Drljevic-Nielsen A, Donskov F, Mains JR, Andersen MB, et al · · 2022 · cited 6× · PMID 34910540 · DOI 10.2214/ajr.21.26911

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