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Clinical Trials in Italy / NCT06774326
Recruiting Observational

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

NCT06774326 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-02-14
Last updated
2025-01-14

Condition(s) studied

Cardiac ImagingCardiac Imaging TechniquesLymphomaHodgkin Disease

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Other trials for the same condition

Italian Study of Patients With Lymphoma Recruiting
RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease Active, not recruiting
Role of Spectral CT in the Diagnosis of Myocarditis/MINOCA in Patients Undergoing cardioCT Investigations for Acute Chest Pain Recruiting
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas Active, not recruiting
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774326 on ClinicalTrials.gov ↗ ← All trials in Italy