Dual-energy SPEctral CT to Evaluate Response to First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer

NCT ID: NCT06863857

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-31

Brief 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.

Detailed Description

In the field of kidney cancer, where PET with FDG or other tracers is not valid due to the high number of false negatives, new techniques for radiological evaluation of the disease are a clinical necessity. The evaluation of parameters derived from the use of dual-energy spectral computed tomography (CT), such as IC and Zeffective, at baseline and after 3 and 6 months of systemic treatment, could provide useful information on how tumor structure (in particular vascularization) evolves during therapy with IO+IO or IO+TKI. In addition, the variation of these parameters could be associated with different outcomes in terms of ORR, PFS and OS. One aspect evaluated is the existence of a correlation between the presence of abundant tumor vascularization (or on the contrary poor vascularization), determined by dual-energy spectral CT, and the response in terms of ORR and PFS at 3 and 6 months to combinations containing IO+TKI or immunotherapy alone. For prognostic and predictive purposes, the study also intends to verify whether there is a correlation between the presence of gene alterations, CT-derived parameters and response to therapies. The prognostic role of some molecular alterations (ATM, BAP1, KDM5C, MET, MTOR, NF2, PBRM1, PIK3CA, PTEN, SETD2, SMARCB1, TP53, TSC1, TSC2, VHL) will be evaluated and their potential predictive value will be analyzed to understand whether a given mutational structure may be more or less responsive to specific types of treatment.

Conditions

Renal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Massari, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

Irccs Azienda Ospedaliero Universitario Di Bologna

Bologna, BO, Italy

Site Status: RECRUITING

Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco FM Massari, MD

Role: CONTACT

francesco.massari@aosp.bo.it

0511242204

Facility Contacts

FRANCESCO MD MASSARI, MD

Role: primary

francesco.massari@aosp.bo.it

0511242204

Other Identifiers

SPECTRE

Identifier Type: -

Identifier Source: org_study_id