18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma can predict disease progression

Detailed Description
-----------------
In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/ CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma.

Official Title
-----------------
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma

Conditions
-----------------
Lymphoma, Extranodal NK-T-Cell

Intervention / Treatment
-----------------
* Device: 18F-FDG PET/ CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed NK/T-cell lymphoma treated using an anthracycline-containing regimen minimal follow-up at 6 months after the completion of first-line treatment complete medical history and clinicopathological data Exclusion Criteria: secondary malignant disease serious infection or inflammation (e.g., HIV) primary central nervous system lymphoma hepatic or renal dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma<br>The new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors. | Device: 18F-FDG PET/ CT<br>* 18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/ dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10min/bed).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year progression-free survival |  | up to 3 years after initial diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Extranodal NK-T-Cell, Positron-Emission Tomography, Prognosis