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

Recruiting

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

• Registration Number: NCT06774326
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2024-02-14
• Status Verified: 2024-11
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2029-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial damage	36 months after starting CHT	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.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy