Clinical trial · Observational
Improved Assessment of Response in Metastatic Renal Cell Carcinoma Using Spectral-CT
Response Evaluation Criteria in Metastatic Renal Cell Carcinoma: Improved Assessment of Response and Progression by Spectral-CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Neoplasm With Metastasis | — | UNRESOLVED | — |
| Response Evaluation Criteria in Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 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.
- description
- 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.
- measure
- overall survival
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (1)
- measure
- Best response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Minimum 18 years 2. Metastatic renal cell carcinoma 3. Oncologic treatment with immunotherapy or angiogenesis inhibitors 4. The patients have signed an informed consent statement 5. Can cooperate for the examinations Exclusion Criteria: 1. Glomerular filtration fraction below 35 ml/min 2. Allergies or other contraindications to the use of contrast media
References
Publications (1)
- DERIVEDDrljevic-Nielsen A, Donskov F, Mains JR, Andersen MB, Thorup K, Thygesen J, Rasmussen F. Prognostic Utility of Parameters Derived From Pretreatment Dual-Layer Spectral-Detector CT in Patients With Metastatic Renal Cell Carcinoma. AJR Am J Roentgenol. 2022 May;218(5):867-876. doi: 10.2214/AJR.21.26911. Epub 2021 Dec 15. PMID 34910540