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

NCT01357733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

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

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Seok-Goo Cho, MD, PhD · The Catholic University of Korea

  • Joo Hyun O, MD · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-02
Primary Completion
2017-11-29
Completion
2023-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01357733 on ClinicalTrials.gov