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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05662540
Enrollment
40
Registered
2022-12-22
Start date
2023-05-26
Completion date
2026-10-31
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NK/T-cell Lymphoma

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.

Interventions

DEVICEPositron Emission Tomography/Magnetic Resonance (PET/MR)

18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patientsBaselineSUVmax, organs, et al.
The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patientsAfter at least 2 cyclesSUVmax, organs, et al.

Secondary

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

Countries

China

Contacts

Primary ContactWeili Zhao
zwl_trial@163.com+862164370045
Backup ContactPengpeng Xu
pengpeng_xu@126.com+862164370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026