Recruiting

Observational StudyImaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06819475

Conditions

Childhood Cancer

Muscle Weakness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging

Magnetic Resonance Spectroscopy

Physical function assessment

Peripheral blood sample

Skeletal muscle biopsy

Study Details

Brief 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.

Conditions

Childhood Cancer

Muscle Weakness

Study ID

NCT06819475

Start date

Jun 2, 2025

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Survivors

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

experimental: Control

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.

Interventions

Magnetic Resonance Imaging

Non-invasive MRI will be used to measure the major muscle groups in the calf muscle mtOXPHOS in childhood survivors of Acute Lymphoblastic Leukemia (ALL) in SJLIFE cohort and community controls and measure how muscle mitochondria produce energy to function.

Magnetic Resonance Spectroscopy

Non-invasive MRS will be used to measure the major muscle groups in the calf muscle mtOXPHOS in childhood survivors of Acute Lymphoblastic Leukemia (ALL) in SJLIFE cohort and community controls and measure how muscle mitochondria produce energy to function.

Physical function assessment

As part of the SJLIFE visit in the Human Performance Lab, the participant's physical health will be assessed by testing muscle strength, physical function, and lean muscle mass.

Peripheral blood sample

Peripheral blood sample will be used to evaluate muscle morphology, mitochondrial health and epigenetic differences in the muscles of survivors and age/sex-matched community controls.

Skeletal muscle biopsy

Muscle biopsy will be used to evaluate muscle morphology, mitochondrial health and epigenetic differences in muscles of survivors and age/sex-matched community controls.

Muscle Ultrasound

Bilateral quadriceps and calf muscle ultrasound will be used to measure muscle volume by calculating the cross-sectional area using the Cavalieri method.

Primary outcome measure

To explore feasibility of MRI/MRS to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of 31P-MRS to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of 1H-MRS to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of CrCEST MRI to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of Fat Fraction MRI to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of Muscle Ultrasound to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of Muscle Biopsy to measure OXPHOS capacity [ Time Frame: Baseline ]
To explore feasibility of mtDNA-CN to measure OXPHOS capacity [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Puneet Bagga, PhD

888-226-4343 referralinfo@stjude.org

Puneet Bagga, PhD

referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Puneet Bagga, PhD

888-226-4343 referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

Survivor
Acute Lymphoblastic Leukemia
Adult
ALL
Healthy Volunteer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-18.