Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Weill Medical College of Cornell University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Weill Medical College of Cornell University
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00754117
First received: September 15, 2008
Last updated: October 27, 2010
Last verified: October 2010
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Purpose
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:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- 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:
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 May 16, 2013