Using advanced CT scans to monitor treatment in kidney cancer patients
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
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06863857
This study tests if advanced CT scans can help track how well treatments are working for people with metastatic kidney cancer who are receiving new combination therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Bologna, BO and 1 other locations) |
| Trial ID | NCT06863857 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of dual-energy spectral computed tomography (CT) in monitoring treatment responses in patients with metastatic clear cell renal cancer. It focuses on patients receiving first-line therapies that combine immunotherapy and targeted drugs. By analyzing changes in CT-derived parameters over time, the study aims to correlate these changes with treatment outcomes and molecular alterations in tumor tissue. The goal is to improve the understanding of how tumor characteristics evolve during therapy and their relationship with patient responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of metastatic clear cell renal cancer who have not received prior treatment.
Not a fit: Patients with non-clear cell renal cancer or those who have previously undergone treatment for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies for patients with metastatic clear cell renal cancer.
How similar studies have performed: While the use of dual-energy spectral CT is a relatively novel approach in this context, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO and 1 other locations
- Irccs Azienda Ospedaliero Universitario Di Bologna — Bologna, BO, Italy (RECRUITING)
- Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Massari, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francesco FM Massari, MD
- Email: francesco.massari@aosp.bo.it
- Phone: 0511242204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Cancer, Dual energy spectral CT