Clinical trial NCT06863857: Dual-energy SPEctral CT to Evaluate Response to First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cancer
Keywords: Dual energy spectral CT
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with metastatic ccRCC and who comply with study inclusion and exclusion criteria

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.

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

Primary outcomes:
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
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From enrollment to 12 months of sistemic therapy
measure: Progression-free survival (PFS)
timeFrame: From enrollment to 6 months of sistemic therapy
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs Azienda Ospedaliero Universitario Di Bologna
state: BO
city: Bologna
country: Italy
facility: Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Francesco Massari, MD
role: PRINCIPAL_INVESTIGATOR
References: