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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Irccs Azienda Ospedaliero Universitario Di Bologna
RECRUITING
Bologna
Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna
RECRUITING
Bologna
Contact Information
Primary
Francesco FM Massari, MD
francesco.massari@aosp.bo.it
0511242204
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov