Role of Spectral CT in the Evaluation of Cardiotoxicity in Patients With Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma Treated With Anthracyclines (AntraCardioTox)

To evaluate the diagnostic capability of Spectral CT (performed with contrast agent as part of routine oncological follow-up) in detecting signs of acute and chronic early-onset cardiac toxicity from anthracyclines in patients with Hodgkin's lymphoma and diffuse large B-cell lymphoma undergoing treatment regimens that include a drug from this family.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Hodgkin Disease; Cardiac Imaging Techniques; Cardiac Imaging

Detailed Description

To evaluate the diagnostic capability of Spectral CT, performed with contrast agent during routine oncological follow-ups, in detecting signs of acute and chronic early-onset cardiac toxicity caused by anthracyclines in patients with Hodgkin's lymphoma and diffuse large B-cell lymphoma undergoing treatment regimens including anthracycline-based drugs. Spectral CT provides advanced data, such as iodine maps and tissue characterization, allowing for the identification and quantification of hyperemia, edema, and fibrosis. These findings are particularly promising in cardiovascular imaging, where tissue characterization and early detection of myocardial damage (edema or fibrosis) are traditionally achieved with cardiac MRI (cardio-MRI).

In clinical oncology, anthracyclines improve survival rates but are associated with cardiotoxic effects, classified as acute (up to two weeks after therapy), early chronic (within one year), or late chronic (years or decades later), often irreversible. Anthracycline-related cardiac toxicity is dose-dependent and varies from subclinical alterations to overt symptoms such as arrhythmias, fibrosis, and heart failure. Early detection of myocardial damage with imaging techniques is critical for initiating cardioprotective therapy, which can significantly improve cardiac outcomes.

Currently, functional imaging modalities like echocardiography and cardio-MRI are used. While echocardiography offers functional data such as LVEF and strain, cardio-MRI provides more precise and reproducible measurements and structural data (e.g., edema via T2 mapping and fibrosis via late gadolinium enhancement, LGE). Structural markers, such as positive LGE and elevated T1 mapping or ECV values, are highly sensitive and can detect damage before functional decline, enabling earlier intervention. However, cardio-MRI has limitations, such as long acquisition times, high costs, and contraindications like claustrophobia.

With the introduction of Spectral CT, studies have shown that advanced CT scanners can also visualize and quantify myocardial fibrosis (as late-iodine enhancement, LIE) and measure ECV, comparable to cardio-MRI. This suggests that Spectral CT could become a "one-stop-shop" modality, capable of assessing both the patient's primary disease and signs of anthracycline-induced cardiotoxicity through post-processing of the same images, even in subclinical stages.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Vincenzo Russo, MD; Phone Number: +390512144747; Email: vincenzo.russo@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Hodgkin's lymphoma and diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines will participate in the study. They will be enrolled and undergo CT and MRI follow-ups conducted by the cardiac radiology team.

Description

Inclusion Criteria:

• Patients with Hodgkin's lymphoma or diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines
• Age ≥18 years
• Informed consent obtained

Exclusion Criteria:

• Absolute or relative contraindications to CT examination and/or administration of iodinated contrast agents (e.g., pregnancy, severe renal insufficiency in non-dialysis patients with GFR <15-30 ml/min/1.73m²).
• Patients with a concomitant positive history of cardiovascular disease (e.g., myocardial infarction, known coronary artery disease, heart failure, arrhythmias, prior myocarditis, cardiomyopathies).
• History of mediastinal radiotherapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial damage	Diagnosis of the presence of acute myocardial damage (hyperemia present) or chronic damage (hyperemia absent) based on the evaluation of the following parameters obtained from Spectral CT: Increased ECV (ECV value above the upper limit of normality, set at 30%).; Presence of Late Iodine Enhancement (LIE) in the myocardium (areas of myocardial hyperdensity due to late-phase iodine contrast accumulation) and its relative extent.; Presence of Hyperemia or Hypoperfusion using the Spectral "Iodine No Water" parameter (visual scoring of hyper- or hypodense areas; consideration of a possible quantitative score in mgI/ml).; Diagnosis of myocardial damage due to chemotherapy (CHT) based on clinical practice upon hospital discharge.	36 months after starting CHT

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Vincenzo Russo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms; Heart Diseases; Immune System Diseases; Neoplasms by Histologic Type; Chemically-Induced Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease; Cardiotoxicity
• Other Study ID Numbers: AntraCardioTox Linfoma Spectra

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