Imaging Muscle Energy Production in Childhood ALL Survivors
This study is looking at how muscles produce energy in childhood survivors of Acute Lymphoblastic Leukemia (ALL), a type of blood cancer, who also have muscle weakness. We want to understand why some survivors experience muscle weakness. We'll use special MRI and MRS scans to measure how well your calf muscles produce energy. We'll also assess your physical health, muscle strength, and collect blood and muscle samples. This study aims to see if these imaging techniques are good ways to measure muscle energy production and how it relates to muscle weakness in survivors. You can join if you are an ALL survivor or a healthy volunteer, aged 18 or older, and have low muscle mass.
- Study design
- This interventional study plans to enroll 60 participants, including childhood ALL survivors and healthy volunteers. It will compare muscle function between these two groups.
- What's involved
- You will undergo non-invasive MRI and MRS scans of your calf muscle, physical function assessments, and provide a peripheral blood sample. Some participants may also have a muscle biopsy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for measuring OXPHOS capacity are assessed at Baseline.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors
At a glance
Conditions
NCT06819475
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
St. Jude Children's Research Hospital
Memphis, Tennesseestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Puneet Bagga, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- To explore feasibility of MRI/MRS to measure OXPHOS capacityBaseline
Multimodal MR imaging will be performed in two appointments. The first appointment will consist of Part 1 (approximately 1 hour) and Part 2 (approximately 30 minutes). There will be a 5-10 minute break between the two parts. The second appointment will consist of Part 1 (approximately 1 hour).
- To explore feasibility of 31P-MRS to measure OXPHOS capacityBaseline
This will be performed with a 7-cm diameter 1H/31P dual-tuned surface/volume coil using an unlocalized free induction decay (FID) sequence: number of points = 512, averages = 2-5, and TR = 2.4-5 seconds, with 4 dummy scans. TPCr is determined by fitting the signal intensity of PCr following plantar flexion exercise to a mono-exponential function. Additionally, we will acquire a steady state 31P-MR spectra for phosphorylated metabolite quantification (sec).
- To explore feasibility of 1H-MRS to measure OXPHOS capacityBaseline
This will be performed on a Siemens 3T scanner using Point RESolved Spectroscopy (PRESS) 31 sequence. A water-suppressed 1H MR spectrum will be acquired from a voxel positioned in gastrocnemius and soleus muscles. 1H MRS data will be processed using LCModel providing the metabolite levels (mM).
- To explore feasibility of CrCEST MRI to measure OXPHOS capacityBaseline
We will perform CrCEST MRI to map calf muscle Cr recovery kinetics (TCrCEST) following plantar flexion exercise (sec).
- To explore feasibility of Fat Fraction MRI to measure OXPHOS capacityBaseline
We will perform Dixon MRI to quantify intramuscular fat fraction (IFF %) in the calf.
- To explore feasibility of Muscle Ultrasound to measure OXPHOS capacityBaseline
Participants will lay supine with legs fully extended with their ankles stabilized in neutral. Customized templates will be strapped on the thigh and consist of five to eight 2-cm slices with a 1-cm gap between slices. Using transmission gel, a continuous, single view will be measured by transversely moving the probe across the thigh in approximately four seconds to acquire images of the rectus femoris (RF) and the vastus lateralis (VL), ensuring minimal pressure is applied to the skin to avoid muscle compression. Bilateral calf muscle CSA will be assessed in the same manner.
- To explore feasibility of Muscle Biopsy to measure OXPHOS capacityBaseline
A vacuum-assisted biopsy device and ultrasound guidance will be used to obtain skeletal muscle samples. The procedure is performed under local anesthesia with the patient in supine position. The needle will be inserted into the vastus lateralis, accessed through a 2-3 mm incision, under local anesthesia. When the needle is removed, a small section of muscle will remain with the needle. Two samples will be obtained during the procedure. One sample will be analyzed for satellite cell content and morphology. The second sample will be analyzed for mtDNA-CN and epigenetic profile.
- To explore feasibility of mtDNA-CN to measure OXPHOS capacityBaseline
Peripheral blood samples will be drawn and analyzed for mtDNA-CN, metabolic and epigenetic profile and compared to the muscle sample.