NCT00754117CompletedNot Applicable
Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
Weill Medical College of Cornell University1 site in 1 country8 target enrollmentStarted: May 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
Study Overview
Brief Summary
Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
- •Patients must have received no prior anti-lymphoma therapy.
- •Age >18 years.
- •Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Patients who have known HIV infection.
- •Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.
Outcomes
Primary Outcomes
evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
Time Frame: after 2 cycles of chemotherapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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