Hyperpolarized 13C-MRI and Metabolomics for Immune-related Adverse Events

NCT06243250 | Unknown DMC FDA Drug

• 1 other identifier: DNP_irAE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project investigates immune-related adverse events (irAEs) in cancer patients treated with immune checkpoint inhibitors (ICIs), focusing on metabolic changes. It explores how glucose metabolism in the spleen, which mirrors immune activity, might predict irAEs. Using advanced imaging like hyperpolarized (HP) 13C-MRI and metabolomics, the study aims to detect metabolic flux in the spleen, potentially offering early prediction and risk categorization of irAEs. The 3-year study will involve 30 cancer patients on ICIs, comparing those with and without irAEs. It hypothesizes that splenic metabolic alterations seen in HP 13C-MRI can forecast and categorize irAE severity, improving our understanding of irAEs and potentially guiding new treatments.

Conditions

Immune-related Adverse Event

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Metabolic activity in spleen measured as pyruvate-to-lactate conversion rate

  The pyruvate-to-lactate conversion calculated by kinetic modeling-based conversion rate of pyruvate-to-lactate (kPL) and model-free metric (signal-to-noise ratio and area-under-curve).

  Data analysis within 7 days after HP 13C-MRI

Study Arms (3)

with irAE

Cancer patients who develop irAE after ICIs treatment.

Diagnostic Test: Hyperpolarized 13C-MRI

without irAE

Cancer patients who do not develop irAE after 3 months of ICIs treatment.

Diagnostic Test: Hyperpolarized 13C-MRI

healthy volunteer

Healthy volunteer.

Diagnostic Test: Hyperpolarized 13C-MRI

Interventions

Hyperpolarized 13C-MRI DIAGNOSTIC_TEST

Metabolic MRI using IV injection of hyperpolarized \[1-13C\]pyruvate.

healthy volunteer; with irAE; without irAE

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A delicate multidiscipline immune-oncologic board will screen the patients who develop acute phase irAEs, which include colitis, endocrinopathy, hepatitis, pneumonitis, and skin toxicity. The diagnosis of the irAEs is determined by clinical, laboratory, standard-of-care imaging, and histopathologic features when biopsy is necessary.

You may qualify if:

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

You may not qualify if:

• Patients undergoing ICIs:
• Life-threatening irAEs (CTCAE ≥ grade 4).
• Abnormal spleen attributable to other diseases (e.g., liver cirrhosis related splenomegaly or primary/metastatic splenic tumors).
• Pregnant or breast-feeding women.
• Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
• 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).
• Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase \>20 × upper limit of normal \[ULN\] or bilirubin \> 10 × ULN).
• Severe renal impairment (eGFR \<30 ml/min/1.73m2).
• Healthy volunteers:
• Pregnant or breast-feeding women.
• Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
• Body mass index (BMI) \>35 kg/m2.
• 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.
• Need for medication due to any medical condition within the last 14 days.
• History of substance abuse (e.g., alcoholism with blood alcohol concentration ≥0.08%).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial hospital

Taoyuan District, 333, Taiwan

RECRUITING

Study Officials

• Ying-Chieh Lai, MD

  Chang Gung Memorial Hospital, Link

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Chieh Lai, MD

CONTACT

+88633281200; cappolya@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)