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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Positron Emission Tomography/Magnetic Resonance (PET/MR)

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

NCT ID

NCT05662540

First Posted

November 13, 2022

Last Updated

June 20, 2023

Sponsor

Ruijin Hospital

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

NK/T-cell Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial