Trial Information
Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma
Inclusion Criteria:
- CD20+ diffuse large B cell lymphoma confirmed
- Therapy naïve for lymphoma
- 19 years or older
- Written informed consent
Exclusion Criteria:
- Cannot understand informed consent
- Age under 19 years old
- Previous chemotherapy or radiation therapy for lymphoma
- Known pregnancy or urine/serum hCG (+)
- Unable to lie down still on back for about 30 minutes
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles
Outcome Description:
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients
Outcome Time Frame:
baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP
Safety Issue:
No
Principal Investigator
Seok-Goo Cho, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Catholic University of Korea
Authority:
Korea: Food and Drug Administration
Study ID:
KC11EISI0293
NCT ID:
NCT01357733
Start Date:
March 2012
Completion Date:
March 2016
Related Keywords:
- Lymphoma, Large B-Cell, Diffuse
- Diffuse, Large B-Cell, Lymphoma
- 18F Fluorodeoxyglucose
- Radionuclide-Emission Computed Tomography
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse