Dual-energy SPEctral CT to Evaluate Response to First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer
Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Mar 6, 2025
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a special type of CT scan called dual-energy spectral CT to see how well it can help monitor treatment in patients with metastatic clear cell renal cancer, which is a type of kidney cancer that has spread to other parts of the body. The researchers want to find out if this advanced imaging technique can provide useful information about how patients are responding to their first-line treatments, which include combinations of immunotherapy (a type of treatment that helps the immune system fight cancer) and targeted therapies (medications that specifically attack cancer cells). They will also analyze tumor samples to see if there are any genetic changes that might affect treatment response.
To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of clear cell renal cancer that has spread. They should not have received any previous treatment for this cancer and must be starting a new treatment plan based on current medical guidelines. Participants who join the study can expect to undergo the dual-energy spectral CT scan and provide a tissue sample for further analysis. This research is currently recruiting participants, and everyone involved will need to give their consent to take part in the study.
Gender
ALL
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
About Irccs Azienda Ospedaliero Universitaria Di Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, Bo, Italy
Bologna, , Italy
Patients applied
Trial Officials
Francesco Massari, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported