13C Pyruvate DNP MR Spectroscopy for Lymphoma Treatment Response Assessment

NCT05600361 | Unknown

• 1 other identifier: MOST 111-2314-B-182A-042
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Conditions

Patient Outcome Assessment

Outcome Measures

Primary Outcomes (2)

• Assessment of early treatment response of lymphoma patients using 13C pyruvate DNP MR spectroscopy

  The changes in metabolic imaging biomarker levels

  2 years

• Assessment of early treatment response of lymphoma patients using 13C pyruvate DNP MR spectroscopy

  The changes in metabolic tumor sizes

  2 years

Study Arms (1)

Patients having 13C Pyruvate DNP for lymphoma early treatment response evaluate

OTHER

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.

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

Interventions

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

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.

Patients having 13C Pyruvate DNP for lymphoma early treatment response evaluate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide signed informed consent
• Willing to receive 13C-pyruvate DNP MRS and return for post-treatment evaluation for the scheduled follow up imaging about 1 week after initiation of chemotherapy.
• Willing to receive therapy and follow-up as suggested by the tumor board and combined conference meeting in our institution
• Presence of enlarged neck lymph nodes and/or spleen to serve as localized target for 3C-pyruvate DNP MRS

You may not qualify if:

• Contraindicated to MRI study: such as cardiac pacemaker, cochlear implantation, metallic object within eyeball
• Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobilit
• Contraindicated to MRI study: such as cardiac pacemaker, cochlear implantation, metallic object within eyeball
• Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobilit

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Yu-Hsiang Juan, MD

CONTACT

+886-9-75366388; Jonat126@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using 13C pyruvate DNP MR spectroscopy to evaluate for early treatment response in patients with lymphoma

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 31, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 31, 2022

Record last verified: 2022-10