Investigating metabolic changes in cancer patients experiencing immune-related adverse events

Integrated Precision Imaging for Immune-related Adverse Events: Hyperpolarized 13C-MRI and Metabolomics

This study is testing if changes in metabolism can help predict immune-related side effects in cancer patients receiving new immune treatments.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Taoyuan)
• Trial ID: NCT06243250 on ClinicalTrials.gov

What this trial studies

This project examines immune-related adverse events (irAEs) in cancer patients treated with immune checkpoint inhibitors (ICIs) by focusing on metabolic changes in the spleen. It utilizes advanced imaging techniques, specifically hyperpolarized (HP) 13C-MRI, to detect metabolic flux that may predict the occurrence and severity of irAEs. The study will involve 30 cancer patients over three years, comparing those with and without irAEs to identify potential biomarkers for early prediction and risk categorization. By integrating metabolomics and MR fingerprinting, the research aims to enhance understanding of irAEs and inform personalized treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include cancer patients aged 20 and older who are undergoing treatment with immune checkpoint inhibitors and may or may not be experiencing immune-related adverse events.

Not a fit: Patients with life-threatening immune-related adverse events or those with abnormal spleen conditions unrelated to cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of immune-related adverse events in cancer patients, enhancing patient safety and treatment outcomes.

How similar studies have performed: While the approach of using metabolic imaging to predict adverse events is novel, similar studies have shown promise in understanding tumor responses to immune therapies.

Eligibility criteria

Inclusion Criteria

Patients undergoing ICIs:

1. Inform consent obtained.
2. Patients more than or equal to 20-year-old.
3. Patients developing IRAEs or not, including but not limited to the following events: colitis、endocrinopathy、hepatitis、pneumonitis、skin toxicity.

Healthy volunteers:

1. Inform consent obtained.
2. Patients more than or equal to 20-year-old.

Exclusion Criteria

Patients undergoing ICIs:

1. Life-threatening irAEs (CTCAE ≥ grade 4).
2. Abnormal spleen attributable to other diseases (e.g., liver cirrhosis related splenomegaly or primary/metastatic splenic tumors).
3. Pregnant or breast-feeding women.
4. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
5. Intercurrent illness that will affect the compliance of the patient during the MRI study (e.g., active infection, symptomatic congestive heart failure, uncontrollable angina, arrhythmia, psychiatric disorders, dyspnea, or diarrhea).
6. Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase \>20 × upper limit of normal \[ULN\] or bilirubin \> 10 × ULN).
7. Severe renal impairment (eGFR \<30 ml/min/1.73m2).

Healthy volunteers:

1. Pregnant or breast-feeding women.
2. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
3. Body mass index (BMI) \>35 kg/m2.
4. Significant clinical history of any kind, including but not limited to the following conditions: diabetes mellitus (DM), hypertension (HTN), heart disease, liver disease, kidney disease, blood disorders, immune system-related diseases, etc.
5. Need for medication due to any medical condition within the last 14 days.
6. History of substance abuse (e.g., alcoholism with blood alcohol concentration ≥0.08%).

Where this trial is running

Taoyuan

• Chang Gung Memorial hospital — Taoyuan, Taiwan (Recruiting)

Study contacts

• Principal investigator: Ying-Chieh Lai, MD — Chang Gung Memorial Hospital, Link
• Study coordinator: Ying-Chieh Lai, MD

Conditions Immune-related Adverse Event; Immune Checkpoint inhibitor; Spleen; Hyperpolarized 13C-MRI; Pyruvate