Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma
Primary Purpose
Lymphoma, T-Cell, Peripheral
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, T-Cell, Peripheral focused on measuring Lymphoma, T-Cell, Peripheral, Positron-Emission Tomography, Prognosis
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed PTCL
- 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
PTCL patients with 18F-FDG PET/CT
Arm Description
18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria
Outcomes
Primary Outcome Measures
Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
Secondary Outcome Measures
3 year progression-free survival
Full Information
NCT ID
NCT03051568
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
NCT03051568
Brief Title
Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma
Official Title
Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography /Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral 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 a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in PTCL.
Detailed Description
In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in PTCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Peripheral
Keywords
Lymphoma, T-Cell, Peripheral, 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
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PTCL patients with 18F-FDG PET/CT
Arm Type
Experimental
Arm Description
18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria
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 (8-10 min/bed).
Primary Outcome Measure Information:
Title
Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
Time Frame
baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)
Secondary 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 PTCL
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
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Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma
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