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

This study is currently recruiting participants.
Verified October 2010 by Weill Medical College of Cornell University

First Received on September 15, 2008.  
Last Updated on October 27, 2010  
History of Changes
This Clinical Trial Sponsored By: Weill Medical College of Cornell University
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00754117
 

Purpose for Clinical Trial

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).

Condition
Diffuse Large B-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Nuclear Scans

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures For Clinical Trial:

  • evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy [ Time Frame: after 2 cycles of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

All patients

All patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed diffuse large b cell lymphoma patients planning to receive 6-8 cycles of R/CHOP chemotherapy.

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754117

Contacts
Contact: Rebecca Elstrom, MD 212-746-2063 ree2001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact         pwg2002@med.cornell.edu    
Principal Investigator: Rebecca Elstrom, MD            
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Rebecca Elstrom, MD Weill Medical College of Cornell University
  More Information

Additional Information:

WCMC website&nbsp

No publications provided

Responsible Party: Dr. Rebecca Elstrom, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00754117    
History of Changes
Other Study ID Numbers: 0801009588
Study First Received: September 15, 2008
Last Updated: October 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

diffuse large b cell lymphoma
newly diagnosed

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 21, 2012

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