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

March 6, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Irccs Azienda Ospedaliero Universitario Di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to first-line drug therapy (with immuno-combinations) in patients with metastatic renal cell carcinoma
Time Frame: From enrollment to 6 months of systemic therapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From enrollment to 12 months of sistemic therapy
for prognostic value of dual-energy spectral CT-derived parameters: Overall Survival (OS) at 12 months For prognostic impact of molecular alterations: OS at 12 months after initiation of therapy.
From enrollment to 12 months of sistemic therapy
Progression-free survival (PFS)
Time Frame: From enrollment to 6 months of sistemic therapy
for prognostic value of dual-energy spectral CT-derived parameters: Overall Survival (OS) at 12 months and Progression-Free Survival (PFS) at 6 months after initiation of therapy.
From enrollment to 6 months of sistemic therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Francesco Massari, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

June 18, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECTRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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