Cardiac ImagingAntraCardioToxNCT06774326
Role of Spectral CT in the Evaluation of Cardiotoxicity in Patients With Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma Treated With Anthracyclines
An observational study of Cardiac Imaging and Cardiac Imaging Techniques, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Imaging, Cardiac Imaging Techniques, Lymphoma
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2024to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with Hodgkin's lymphoma or diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines
- Age ≥18 years
- Informed consent obtained
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
About this study
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.
Read the 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.
- Conditions
- Cardiac Imaging, Cardiac Imaging Techniques, Lymphoma, Hodgkin Disease
- Medical subject headings
- Lymphoma, Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months after starting CHT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start14 Feb 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ImagingStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Russo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774326
- Sponsor's protocol ID
- AntraCardioTox Linfoma Spectra
- Acronym
- AntraCardioTox
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Spectral CT in the Evaluation of Cardiotoxicity in Patients With Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma Treated With Anthracyclines
- ClinicalTrials.gov ID
- NCT06774326
- Acronym / sponsor ID
- AntraCardioTox / AntraCardioTox Linfoma Spectra
- Conditions
- Cardiac Imaging, Cardiac Imaging Techniques, Lymphoma, Hodgkin Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with Hodgkin's lymphoma or diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines
- Age ≥18 years
- Informed consent obtained
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial damage
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Russo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Imaging and Cardiac Imaging Techniques, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Russo, MD (+390512144747, vincenzo.russo@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial damage (time frame: 36 months after starting CHT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.