Clinical trial · Observational
Dual-energy SPEctral CT to Evaluate Response to First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer
Dual-energy SPEctral CT to Evaluate Response to New First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer and the Association of Its Parameters With Molecular Alterations
- 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)
To evaluate the utility of dual-energy spectral computed tomography (CT) scan in monitoring treatment in patients with metastatic clear cell carcinoma of the kidney. In particular, to analyze the use of spectral CT in patients who are candidates to receive first-line treatment based on combinations of immunotherapy and molecularly targeted drugs. In particular, the parameters derived from the use of this technology and their variation during therapy will be analyzed together with some possible molecular alterations highlighted by the analysis of the tumor tissue previously taken from the patient, relating them to the response to first-line therapy with immuno-combinations.
Conditions
Conditions (1)
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 Cancer | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response to first-line drug therapy (with immuno-combinations) in patients with metastatic renal cell carcinoma
- timeFrame
- From enrollment to 6 months of systemic therapy
- description
- IC and Zeffective parameters will be compared between responders and non-responders. the outcome studied will be the Overall Response Rate (ORR) assessed radiologically according to RECIST 1.1 criteria
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- From enrollment to 12 months of sistemic therapy
- description
- for prognostic value of dual-energy spectral CT-derived parameters: Overall Survival (OS) at 12 months For prognostic impact of molecular alterations: OS at 12 months after initiation of therapy.
- measure
- Progression-free survival (PFS)
- timeFrame
- From enrollment to 6 months of sistemic therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years * Patients with histological or cytological diagnosis of clear cell RCC * Patients with metastatic disease documented by imaging or biopsy of the secondary site * Patients who have not had previous treatment for RCC * Patients with an indication for first-line medical treatment based on IO+TKI, IO+IO as per clinical practice at the Medical Oncology Unit of the IRCCS University Hospital of Bologna * Patients who have already had a dual-energy spectral total-body CT with MDC within 4 weeks of treatment initiation * Availability of a formalin-fixed, paraffin-embedded histological block (FFPE) stored for a period \<15 years, for the execution of molecular analysis for the search for alterations of the genes ATM, BAP1, KDM5C, MET, MTOR, NF2, PBRM1, PIK3CA, PTEN, SETD2, SMARCB1, TP53, TSC1, TSC2, VHL * Patients who knowingly express consent to participate in the study after signing the consent Exclusion Criteria -None
References
Publications (0)
Data not yet available