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13C Pyruvate DNP MR Spectroscopy for Lymphoma Treatment Response Assessment

NCT05600361 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-10-31

No results posted yet for this study

Summary

This study has two stages and the aims are as follows:

Aim 1:

In Stage 1 of this study, the investigators aim to recruit first-time diagnosed lymphoma patients, to understand the changes of metabolites before and after treatment, and to evaluate the ability of hyperpolarized 13C-labeled pyruvate from dynamic nuclear polarization (DNP) magnetic resonance spectroscopy (MRS) for detecting early treatment response in these patients.

The pre-treatment metabolic imaging biomarker levels will be compared to the followings:

1. Post-treatment metabolites from 13C-pyruvate DNP MRS after the first week of chemotherapy
2. Interval change in tumor size
3. ADC values from diffusion weighted imaging (DWI), SUV values from 18F-FDG PET/CT before and after the first week of chemotherapy
4. Pre-treatment and interim follow up SUV values from 18F-FDG PET/CT
5. Post-treatment outcome and to understand the change of metabolites before and after treatment and if possible, evaluate treatment outcome using the above imaging biomarkers

Aim 2:

In Stage 2 of this study, the investigators aim to recruit lymphoma patients with proven relapse after treatment, to understand the changes of metabolites before and after treatment, to compare the metabolite changes with Stage 1 patients and to evaluate the ability of hyperpolarized 13C-labeled pyruvate from DNP MRS for detecting early treatment response in these patients.

Conditions

  • Patient Outcome Assessment

Interventions

DRUG

hyperpolarized 13C-labeled pyruvate from dynamic nuclear polarization (DNP) magnetic resonance spectroscopy

In stage 1, we expected to enroll 8 first-time diagnosed lymphoma patients referred from clinicians for 13C-pyruvate DNP MRS. In stage 2, another 8 patients with proven relapse will be referred from clinicians for 13C-pyruvate DNP MRS. We will collect related clinical information, patient follow up information, including treatment outcome, and imaging parameters from MRI and PET/CT.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-12-31
Completion
2024-12-31

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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 NCT05600361 on ClinicalTrials.gov