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

NCT06863857 | Recruiting

• 1 other identifier: SPECTRE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Cancer

Keywords

Dual energy spectral CT

Outcome Measures

Primary Outcomes (1)

• Response to first-line drug therapy (with immuno-combinations) in patients with metastatic renal cell carcinoma

  IC and Zeffective parameters will be compared between responders and non-responders. the outcome studied will be the Overall Response Rate (ORR) assessed radiologically according to RECIST 1.1 criteria

  From enrollment to 6 months of systemic therapy

Secondary Outcomes (2)

• Overall Survival (OS)

  From enrollment to 12 months of sistemic therapy

• Progression-free survival (PFS)

  From enrollment to 6 months of sistemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with metastatic ccRCC and who comply with study inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Irccs Azienda Ospedaliero Universitario Di Bologna

Bologna, BO, 40138, Italy

RECRUITING

Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue sample

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Francesco Massari, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco FM Massari, MD

CONTACT

0511242204; francesco.massari@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 7, 2025
• Study Start: September 30, 2024
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)