Back to results18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma
Primary Purpose
Lymphoma, Extranodal NK-T-Cell
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FDG PET/ CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma, Extranodal NK-T-Cell focused on measuring Lymphoma, Extranodal NK-T-Cell, Positron-Emission Tomography, Prognosis
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.
Sites / Locations
- Peking University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma
Arm Description
The new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors.
Outcomes
Primary Outcome Measures
3 year progression-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03051555
First Posted
February 9, 2017
Last Updated
February 9, 2017
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Beijing Municipal Administration of Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03051555
Brief Title
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma
Official Title
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Beijing Municipal Administration of Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Extranodal NK-T-Cell
Keywords
Lymphoma, Extranodal NK-T-Cell, Positron-Emission Tomography, Prognosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma
Arm Type
Experimental
Arm Description
The new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors.
Intervention Type
Device
Intervention Name(s)
18F-FDG PET/ CT
Intervention Description
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).
Primary Outcome Measure Information:
Title
3 year progression-free survival
Time Frame
up to 3 years after initial diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejuan Wang, MD
Phone
86 10-88196364
Email
xuejuan_wang@hotmail.com
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma
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