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

October 23, 2024 updated by: Zhao Weili, Ruijin Hospital

PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nature Killer/T-cell Lymphoma (NKTCL) is a highly heterogeneous, aggressive lymphoma subtype with poor prognosis. Ninty percent of patients have lesions involving the nasal region, other extranodal organs include adrenal glands, gastrointestinal tract, skin and so on. Local tumor infiltration (bone, skin, paranasal sinus, etc) is a poor prognostic factor. Therefore, NK/T-cell lymphomas have high demands on the resolution of fine anatomical structures. PET/CT and nasopharyngeal contrast-enhanced MR are routine examination methods for diagnostic staging and efficacy evaluation, but the images cannot be fused, and the divided examinations bring inconvenience to patients.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200020
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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:

    1. Those with implanted functional electronic devices such as cardiac pacemakers
    2. Carotid aneurysm clipping and other implants are ferromagnetic materials
    3. Implanted perfusion devices such as insulin perfusion pumps
    4. Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
    5. Those who are claustrophobic
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/MR
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)
18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
Time Frame: Baseline
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
Time Frame: After at least 2 cycles
SUVmax, organs, et al.
After at least 2 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.
Time Frame: Baseline up to data cut-off (up to approximately 4 years)
SUVmax, organs, progression-free survival, overall survival, et al.
Baseline up to data cut-off (up to approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-PETMR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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