Hodgkin and non-Hodgkin lymphoma MedDRA version: 17.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.1 Level: HLGT Classification code 10025322 Term: Lymphomas non-Hodgkin's unspecified histology System Organ Class:
Conditions
Interventions
Trade Name: Adriamycin/Doxorubicin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg/ml milligram(s)
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Newly diagnosed Hodgkin or non-Hodgkin lymphoma - Intended curative chemotherapeutic treatment including doxorubicin - Age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Planned mediastinal radiation therapy involving the heart (patients receiving only upper mediastinal radiation therapy can still participate) - Previous chemotherapeutic treatment - Previous mediastinal radiation therapy - Pre-existing HF of any cause (LVEF 30ml/min/1.73 m2) - Impaired liver function (bilirubin > 20 µmol/l) - Contraindications for MR scan (severe claustrophobia, implanted metallic foreign bodies etc.) - Contraindications for PET scan (adenosine intolerance, 2nd or 3rd degree AV block, long QT syndrome, unstable angina pectoris, sinus node dysfunction) - Unwillingness to participate - Unable to give informed consent or unlikely to comply with follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of our study is to investigate the value of the combination of 123I-MIBG and 82Rb PET/MR imaging in early detection of cardiomyopathy and prediction of HF in patients with doxorubicin-treated Hodgkin lymphoma and non-Hodgkin lymphoma. Potentially, serial 123I-MIBG and 82 Rb PET/MR scans during chemotherapy could aid in sensitive detection of cardiotoxicity and guide the modification of conventional antineoplastic regimens.;Secondary Objective: Not applicable;Primary end point(s): Doxorubicin-induced acute mitochondrial damage in cardiomyocytes reflected by declining coronary flow reserve measured by 82Rb PET 24-48 hours post-chemotherapy predicts the development of cardiac interstitial fibrosis measured by increase in cardiac extracellular volume (ECV) by cardiac MR at one year follow-up. ;Timepoint(s) of evaluation of this end point: - Baseline 82Rb PET/MR (prior to chemotherapy) - Acute 82Rb PET/MR (48-72 hours after the first doxorubicin-treatment) - Late MR (12-15 months post-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Doxorubicin-induced acute mitochondrial damage in cardiomyocytes reflected by declining maximal absolute myocardial perfusion measured by 82Rb PET 24-48 hours post-chemotherapy predicts the development of cardiac interstitial fibrosis measured by increase in cardiac ECV by cardiac MR at one year follow-up. - Doxorubicin-induced subacute cardiotoxicity reflected by changes in 123I-MIBG uptake in myocardial adrenergic neurons 3 weeks post-chemotherapy predicts development of cardiac interstitial fibrosis measured by increase in cardiac ECV by cardiac MR at one year follow-up. ;Timepoint(s) of evaluation of this end point: - Baseline 82Rb PET/MR and 123I-MIBG (prior to chemotherapy) - Acute 82Rb PET/MR (48-72 hours after the first doxorubicin-treatment) - Subacute 123I-MIBG (2-3 weeks post-treatment) - Late MR (12-15 months post-treatment) | — |
Countries
Denmark
Contacts
Public ContactDr. Adam Høgsbro Laursen
Rigshospitalet
Outcome results
None listed