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NCT05731375
Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage
Conditions: Doxorubicin Induced Cardiomyopathy, Chemotherapeutic Toxicity, B-cell Lymphoma, T-cell Lymphoma
Sex: All
Ages: 18 Years – N/A
Enrollment: 12
Sponsor: UMC Utrecht
Location: Netherlands
Summary
The goal of this observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and cardiac muscles in muscles in large B- or T-cell lymphoma patients during treatment with (R-)CHOP.
The main question it aims to answer is:• Can 31P-MRS be used to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles in large B- or T-cell lymphoma patients during treatment with (R-)CHOP?To be able to answer this main question, participants will undergo 31P-MRS imaging of the calf muscles and of the heart 3 times during the study period.
Eligibility Criteria
Inclusion criteria:Age ≥ 18 yearsPatients with large B-cell lymphoma or T-cell lymphoma scheduled for 6 full-dose cycles of 1st line immunochemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone with or without rituximab ((reversed) (R-)CHOP).WHO-performance score 0-2.Patients with sufficient Dutch writing and reading skills.Written informed consent.Exclusion Criteria:Contra-indications for 7T MR scanning, including patients with a non-MRI compatible pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; patients with a non-MR compatible aneurysm clip in their brain; patients with claustrophobia, and/or severe obesity.Any circumstances that would impede adherence to study requirements or ability to give informed consent.Medical disorders affecting mitochondrial function; e.g., spinal muscular atrophy.(Other) relevant medical disorders; e.g., comorbidities affecting exercise tolerance.Being under examination for non-diagnosed disease at the time of investigation.
Source: ClinicalTrials.gov (NCT05731375). StuddyBuddy aggregates publicly available trial information.