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

NCT06243250 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-02-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Hyperpolarized 13C-MRI

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

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Ying-Chieh Lai, MD · Chang Gung Memorial Hospital, Link

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243250 on ClinicalTrials.gov