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

May 25, 2018 updated by: Weill Medical College of Cornell University

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
All patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
Time Frame: after 2 cycles of chemotherapy
after 2 cycles of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Rebecca Elstrom, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 8, 2012

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0801009588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe