Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754117
• Other study ID #: 0801009588
• Status: Completed
• Start date: May 2008
• Est. completion date: December 8, 2012

Study information

• Verified date: May 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 8, 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy		after 2 cycles of chemotherapy

External Links

•   WCMC website