PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma

NCT05662540 | Recruiting DMC

• 1 other identifier: NK-PETMR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to evaluate the application value of Positron Emission Tomography/Magnetic Resonance (PET/MR) in the staging and efficacy evaluation of NK/T cell lymphoma, aiming to explore a more accurate system for predicting the prognosis of patients and guiding the treatment.

Conditions

NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients

  SUVmax, organs, et al.

  Baseline

• The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients

  SUVmax, organs, et al.

  After at least 2 cycles

Secondary Outcomes (1)

• Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.

  Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

PET/MR

EXPERIMENTAL

This is a prospective, single-arm clinical study. Subjects who meet the inclusion criteria will receive PET/MR examination within 28 days before treatment after signing the informed consent form for pre-treatment evaluation. Stage I/II patients received PET/MR again 21-35 days after 2 and 4 courses of standard treatment for mid-term and final efficacy evaluation. Stage III/IV patients received PET/MR again 21-35 days after 3 and 6 courses of standard treatment for mid-term and final efficacy evaluation. Follow-up assessments are then continued, every 12 weeks for the first year, and every 24 weeks thereafter (clinical symptoms, physical examination, enhanced CT of the cervix, abdomen, and pelvis, and enhanced MR of the nasopharynx) until disease progression (PD), death, withdrawal of informed consent, or study finish. For subjects with suspected PD, histopathological results should be obtained whenever possible to confirm or exclude PD status.

Device: Positron Emission Tomography/Magnetic Resonance (PET/MR)

Interventions

Positron Emission Tomography/Magnetic Resonance (PET/MR) DEVICE

18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

PET/MR

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016
• Age from 14 to 70 years-old
• ECOG 0-2 score
• Patients with a life expectancy of at least 6 months
• Patient has not been treated before for NK/T cell lymphoma
• Commit to abide by the research procedures and cooperate with the implementation of the whole process of research
• Written informed consent

You may not qualify if:

• \- Subjects who meet any of the following criteria are not eligible for study entry
• Diagnosed aggressive NK cell leukemia
• Pregnant or lactating women
• Liver and kidney insufficiency
• Other PET/MR contraindications:
• Those with implanted functional electronic devices such as cardiac pacemakers
• Carotid aneurysm clipping and other implants are ferromagnetic materials
• Implanted perfusion devices such as insulin perfusion pumps
• Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
• Those who are claustrophobic
• Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Positron-Emission Tomography; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: December 22, 2022
• Study Start: May 26, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

CN (1)