Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography /Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles
Study Overview
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 DLBCL.
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 (1.6 fold of liver SUVmax) 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 DLBCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •newly diagnosed DLBCL
- •treated using an anthracycline-containing regimen with or without rituximab
- •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.
Arms & Interventions
DLBCL patients with 18F-FDG PET/CT
18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria
Intervention: 18F-FDG PET/CT (Device)
Outcomes
Primary Outcomes
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 Outcomes
- 2 year progression-free survival(up to 2 years after initial diagnosis)
Investigators
Xuejuan Wang,MD
Principal Investigator
Peking University Cancer Hospital & Institute