Imaging Muscle Activity for Acute Lymphoblastic Leukemia Survivors

Overseen By Puneet Bagga, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Anticoagulants

Disqualifiers: Cranial radiation, Pregnancy, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how childhood cancer, specifically Acute Lymphoblastic Leukemia (ALL), impacts muscle health later in life. Researchers aim to compare muscle activity and cell content between ALL survivors and healthy individuals. The goal is to understand how these factors relate to physical performance and muscle structure in survivors. Suitable candidates for this trial include adults who survived childhood ALL or healthy volunteers with low muscle mass from the St. Jude Life Cohort. Participants will undergo a skeletal muscle biopsy (a small tissue sample) to collect the necessary data. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that may enhance long-term health outcomes for ALL survivors.

Will I have to stop taking my current medications?

The trial requires that participants not be taking anticoagulants (blood thinners like aspirin or rivaroxaban). If you are on these medications, you would need to stop taking them to participate.

What prior data suggests that this skeletal muscle biopsy is safe?

Research has shown that taking a small sample of muscle tissue, called a biopsy, is generally safe and well-tolerated. In studies with childhood cancer survivors, researchers have used these procedures to learn about muscle changes without causing major problems. These studies have reported no serious side effects directly linked to muscle biopsies. However, like any procedure, minor risks exist, such as soreness or bruising at the sample site. Overall, evidence suggests that this procedure is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to understand muscle health in survivors of acute lymphoblastic leukemia (ALL). Unlike traditional methods that focus on blood tests or imaging, this approach involves a skeletal muscle biopsy to directly examine muscle tissue. This method could provide more detailed insights into how ALL and its treatments affect muscle function and recovery. By comparing muscle health in ALL survivors with healthy controls, the study aims to uncover specific muscle changes and potentially lead to better long-term care strategies for these survivors.

What evidence suggests that this method is effective for understanding muscle weakness in ALL survivors?

Research has shown that survivors of childhood acute lymphoblastic leukemia (ALL) often have weaker muscles and less muscle mass. Studies have found that these survivors typically have less muscle compared to healthy individuals. This muscle weakness partly results from the chemotherapy treatments used to fight cancer.

The current trial will compare muscle activity between ALL survivors and healthy controls. Researchers are examining how well the muscles produce energy, which is crucial for understanding these changes. Gaining insight into these muscle changes can help improve the quality of life for cancer survivors. ^{1 3 4 5 6}

Who Is on the Research Team?

Puneet Bagga, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for survivors of childhood Acute Lymphoblastic Leukemia (ALL) and healthy volunteers interested in studying the effects of cancer and its treatment on muscle weakness. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to be included.

Inclusion Criteria

Survivor- or Control Participant has low muscle mass as defined by relative lean mass z-score of less than or equal to -1 SD (lean mass divided by height in meters squared)

Survivor- Participant is childhood ALL survivor

Survivor- or Control-Participant is able and willing to give informed consent

Exclusion Criteria

Survivor- or Control-Participant has implanted medical devices or metal that would interfere with MRI or MRS

Survivor- or Control-Participant is allergic to local anesthetic (i.e., lidocaine, bupivacaine)

I have had radiation therapy to my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including MRI/MRS sessions, physical function tests, and muscle ultrasound

2 weeks

2 visits (in-person)

Sample Collection

Participants provide peripheral blood and muscle samples for analysis

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Skeletal muscle biopsy

Trial Overview The study uses Magnetic Resonance Spectroscopy, MRI, muscle biopsies, physical function tests, blood samples, and Muscle Ultrasound to compare mitochondrial activity and satellite cell content in muscles between ALL survivors and controls.

How Is the Trial Designed?

Group I: Survivors Experimental Treatment 6 Interventions

Adult survivor of acute lymphoblastic leukemia (ALL) enrolled in St. Jude Life Cohort (SJLIFE).

Group II: Control Experimental Treatment 6 Interventions

Control participants are not a close relative of someone who has received treatment for childhood cancer or a similar illness; age/sex-matched healthy volunteers and recruited from SJLIFE Control cohort and may be recruited from new SJLIFE Controls.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8445321/

Skeletal Muscle and Childhood Cancer - PubMed Central - NIH Low lean mass is one of the most commonly reported outcomes in long-term ALL survivors. Boland et al69 observed lower relative (68.6% vs. 71.4%) lean mass and ...

2. stjude.org stjude.org/care-treatment/clinical-trials/mmiccs-acute-lymphoblastic-leukemia.html

Imaging Muscle Activity in Acute Lymphoblastic Leukemia We are studying a new way to measure the muscle function of survivors of childhood acute lymphoblastic leukemia (ALL) using OXPHOS MRI, which is a kind of ...

3. withpower.com withpower.com/trial/phase-childhood-cancers-1-2025-927db

Imaging Muscle Activity for Acute Lymphoblastic Leukemia ... This N/A medical study run by St. Jude Children's Research Hospital is evaluating whether Skeletal muscle biopsy will have tolerable side effects & efficacy ...

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2013.00049/full

Potential mechanisms for chemotherapy-induced delayed ... There is evidence that survivors of childhood cancers, such as acute lymphoblastic leukemia (ALL), have increased rates of long-term skeletal muscle ...

5. emjreviews.com emjreviews.com/oncology/article/editors-pick-muscle-dysfunction-in-childhood-cancer-biological-mechanisms-and-implications-for-long-term-survivorship/

Editor's Pick: Muscle Dysfunction in Childhood Cancer We present a conceptual outline of childhood cancer treatment with regard to skeletal muscular toxicities and their potential long-term implications.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06819475

Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In ... This pilot study will explore the feasibility of non-invasive metabolic imaging to measure the major muscle groups in the calf muscle mtOXPHOS in childhood ...