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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission Tomography/Magnetic Resonance (PET/MR) | Device | 18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | SUVmax, organs, progression-free survival, overall survival, et al. | Baseline up to data cut-off (up to approximately 4 years) |
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Inclusion Criteria:
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:
Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao | Contact | +862164370045 | zwl_trial@163.com | |
| Pengpeng Xu | Contact | +862164370045 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D009369 |
| Neoplasms |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |