Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients

August 4, 2022 updated by: Sung Hoon Kim, The Catholic University of Korea

Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma

Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) scan at the time of initial staging. The patients will be diagnosed and undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.

After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers from nadir (usually 13 to 16 days after) following the administration of first cycle of R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT study will not impact patient management, except in rare case where newly developed lesion is found and biopsy confirmed.

The same PET/CT system and analysis software will be used for all scans from baseline to surveillance for all patients enrolled in this study.

After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with newly developed lesion will receive different chemotherapy regimen, while patients with stable disease, partial metabolic response or complete metabolic response will continue to receive 3 more cycles of R-CHOP.

After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for response assessment. Selected patients with persistent disease or very bulky tumor volume on initial staging images will receive additional radiation therapy.

The patients will be followed up every 3 months for 2 years from beginning of therapy. Physical examination and lab studies will be done usually every 3 months. Imaging studies will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted when different schedule is applied for surveillance.

The end points are changes in FDG uptake measurements between the baseline and early interim FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response assessment following completion of 6 cycles of R-CHOP with or without radiation therapy assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid Tumors (PERCIST) guideline; and the 2 year disease free survival.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CD20+ diffuse large B cell lymphoma confirmed
  • Therapy naïve for lymphoma
  • 19 years or older
  • Written informed consent

Exclusion Criteria:

  • Cannot understand informed consent
  • Age under 19 years old
  • Previous chemotherapy or radiation therapy for lymphoma
  • Known pregnancy or urine/serum hCG (+)
  • Unable to lie down still on back for about 30 minutes

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interim FDG PET/CT
Single arm study with diagnostic imaging study as the intervention.
Other: Early interim FDG PET/CT after 1 cycle of R-CHOP
FDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles
Time Frame: baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients
baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP
Change from baseline in summed SULpeak after 1 cycle
Time Frame: baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and early interim FDG PET/CT after 1 cycle of R-CHOP in DLBCL patients
baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 year disease free survival
Time Frame: up to 2 years after initial diagnosis
Patients considered to have 2 year disease free survival will be those with complete response after 6 cycles of R-CHOP or isolated persistent disease treated by radiation therapy, AND continuous disease free state for 2 years from the start of therapy (reference standard "success"). All other patients will be considered to not have achieved 2 year disease free survival.
up to 2 years after initial diagnosis
Qualitative response
Time Frame: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Response according to Lugano Classification and Deauville 5 point score. Response according to IWC+PET criteria with qualitative visual analysis of FDG PET/CT using mediastinum as the background reference.
after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Quantitative response
Time Frame: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Response according to PERCIST criteria with change in summed SULpeak in the FDG PET/CT as the background reference.
after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Seok-Goo Cho, MD, PhD, The Catholic University of Korea
  • Principal Investigator: Joo Hyun O, MD, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 2, 2012

Primary Completion (Actual)

November 29, 2017

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC11EISI0293

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.

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