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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Puneet Bagga, PhD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+