Clinical trial · Interventional
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study
NCT05662540CI-TRIAL-00081972recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron Emission Tomography/Magnetic Resonance (PET/MR) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/MR
- 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.
- interventionNames
- Device: Positron Emission Tomography/Magnetic Resonance (PET/MR)
Primary outcomes (2)
- measure
- The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.