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

Primary Purpose

NK/T-cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Positron Emission Tomography/Magnetic Resonance (PET/MR)
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for NK/T-cell Lymphoma

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MR

Arm Description

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.

Outcomes

Primary Outcome Measures

The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
SUVmax, organs, et al.
The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients
SUVmax, organs, et al.

Secondary Outcome Measures

Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.
SUVmax, organs, progression-free survival, overall survival, et al.

Full Information

First Posted
November 13, 2022
Last Updated
June 20, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05662540
Brief Title
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma
Official Title
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK/T-cell Lymphoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET/MR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography/Magnetic Resonance (PET/MR)
Intervention Description
18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.
Primary Outcome Measure Information:
Title
The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
Description
SUVmax, organs, et al.
Time Frame
Baseline
Title
The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients
Description
SUVmax, organs, et al.
Time Frame
After at least 2 cycles
Secondary Outcome Measure Information:
Title
Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.
Description
SUVmax, organs, progression-free survival, overall survival, et al.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu
Phone
+862164370045
Email
pengpeng_xu@126.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili ZHAO
Phone
+862164370045
Ext
610707
Email
zwl_trial@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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