RecruitingNCT06863857

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

50 participants

Start Date

Sep 30, 2024

Study Type

OBSERVATIONAL

Conditions

Renal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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