RecruitingNot Applicable

Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors

United States60 participantsStarted 2025-06-02

Plain-language summary

The participants are being asked to take part in this trial, because the participant is a survivor of childhood cancer or agreed to be part of a volunteer group to understand the relation between cancer and cancer treatment and muscle weakness in survivors of Acute Lymphoblastic Leukemia (ALL). ALL is cancer of the blood and bone marrow. Primary Objective • To compare muscle mtOXPHOS activity and satellite cell content among ALL survivors and controls. Secondary Objective * To evaluate the association between muscle mtOXPHOS, muscle satellite cell content and physical performance in ALL survivors. * To evaluate the association of muscle morphology and epigenetics with muscle mtOXPHOS in ALL survivors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Survivor- or Control-Participant is age 18 years old or older at time of consent and enrolled in SJLIFE. * Survivor- Participant is childhood ALL survivor * Survivor- or Control Participant has low muscle mass as defined by relative lean mass z-score of less than or equal to -0.5 SD (lean mass divided by height in meters squared). * Survivor - Participant is able and willing to give informed consent Exclusion Criteria: * Survivor-Participant has history of cranial radiation. * Survivor- or Control-Participant has implanted medical devices or metal that would interfere with MRI or MRS * Female Survivor- or Control-Participant is pregnant. * Survivor- or Control-Participant is taking anticoagulants (e.g. aspirin, apixaban, coumadin, edoxaban, rivaroxaban) * Survivor- or Control-Participant weighs more than 300 pounds. * Survivor- or Control-Participant is allergic to local anesthetic (i.e., lidocaine, bupivacaine). * Survivor- or Control-Participant cannot lie flat on his/her back for 90 minutes or longer * Survivor- or Control-Participant has a current history of peripheral motor neuropathy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To explore feasibility of MRI/MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of 31P-MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of 1H-MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of CrCEST MRI to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Fat Fraction MRI to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Muscle Ultrasound to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Muscle Biopsy to measure OXPHOS capacity

Timeframe: Baseline

Trial details

NCT IDNCT06819475

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Puneet Bagga, PhD

888-226-4343 referralinfo@stjude.org

View on ClinicalTrials.gov More Childhood Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To explore feasibility of MRI/MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of 31P-MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of 1H-MRS to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of CrCEST MRI to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Fat Fraction MRI to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Muscle Ultrasound to measure OXPHOS capacity

Timeframe: Baseline

To explore feasibility of Muscle Biopsy to measure OXPHOS capacity

Timeframe: Baseline