Hyperpolarized 13C MRI for Cancer Immunotherapy

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT05805358
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized 13C-Pyruvate injection — DRUG
    DNP-MRI for splenic immune function evaluation through hyperpolarized 13C-Pyruvate injection

Study Details

The investigators aim to develop an advanced imaging platform, such as dynamic nuclear polarization (DNP) 13C-MRI, MR fingerprinting (MRF) and MR Relaxometry, which combines with traditional anatomical contrast CT, MRI and PET, and integrate blood/urine metabolomics methods. A comprehensive strategy to thoroughly analyze the immune activation of spleen pattern, microstructure, cell density, red blood cell iron content, immune cell glycolysis and metabolic flow rate.

Key Dates

First listed
Apr 10, 2023
Start date
Nov 1, 2023
Status verified
Aug 2023
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Conventional Imaging Group
    60 participants who accepted ICI treatment will receive conventional imaging
  • Experimental: Next Generation Imaging Group
    30 participants who accepted ICI treatment will receive next generation imaging including MRF and MR Relaxometry and hyperpolarized 13C pyruvate DNP scanning.

Primary Outcome Measure

DNP conversion flux ( pyruvate-to-lactate conversion rate; Kpl) before immunotherapy [ Time Frame: ~1-2 weeks before clinical immunotherapies ]

Central Contacts

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