Lymphoma, Large B-Cell, DiffuseNCT01357733
Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients
A study testing Early interim FDG PET/CT after 1 cycle of R-CHOP in people with Lymphoma, Large B-Cell, Diffuse, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Early interim FDG PET/CT after 1 cycle of R-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2012to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD20+ diffuse large B cell lymphoma confirmed
- Therapy naïve for lymphoma
- 19 years or older
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
About this study
Official title: 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.
Read more
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
- Being tested
- Early interim FDG PET/CT after 1 cycle of R-CHOP
- Keywords
- Diffuse, Large B-Cell, Lymphoma, 18F Fluorodeoxyglucose, Radionuclide-Emission Computed Tomography
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early interim FDG PET/CT after 1 cycle of R-CHOPOther
FDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP
| Study group | Role | What they receive |
|---|---|---|
| Interim FDG PET/CT | Other | Single arm study with diagnostic imaging study as the intervention. Receives: Other: Early interim FDG PET/CT after 1 cycle of R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients
Measured: 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
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
Measured: baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP
Secondary outcomes (3)
2 year disease free survival
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.
Measured: up to 2 years after initial diagnosis
Qualitative response
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.
Measured: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Quantitative response
Response according to PERCIST criteria with change in summed SULpeak in the FDG PET/CT as the background reference.
Measured: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study start2 Mar 2012
- Primary completion29 Nov 2017
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo Hyun O, The Catholic University of Korea
- Investigators
- Seok-Goo Cho, MD, PhD, Principal investigator, The Catholic University of KoreaJoo Hyun O, MD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357733
- Sponsor's protocol ID
- KC11EISI0293
- Status last verified
- Oct 2026
- First submitted
- 13 May 2011
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
PubMed 19403881Michallet AS, Trotman J, Tychyj-Pinel C. Role of early PET in the management of diffuse large B-cell lymphoma. Curr Opin Oncol. 2010 Sep;22(5):414-8. doi: 10.1097/CCO.0b013e32833d5905.
PubMed 20683268Zelenetz AD, Abramson JS, Advani RH, Andreadis CB, Byrd JC, Czuczman MS, Fayad L, Forero A, Glenn MJ, Gockerman JP, Gordon LI, Harris NL, Hoppe RT, Horwitz SM, Kaminski MS, Kim YH, Lacasce AS, Mughal TI, Nademanee A, Porcu P, Press O, Prosnitz L, Reddy N, Smith MR, Sokol L, Swinnen L, Vose JM, Wierda WG, Yahalom J, Yunus F. NCCN Clinical Practice Guidelines in Oncology: non-Hodgkin's lymphomas. J Natl Compr Canc Netw. 2010 Mar;8(3):288-334. doi: 10.6004/jnccn.2010.0021. No abstract available.
PubMed 20202462
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01357733
- Acronym / sponsor ID
- KC11EISI0293
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Diffuse, Large B-Cell, Lymphoma, 18F Fluorodeoxyglucose, Radionuclide-Emission Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 2 Mar 2012 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interim FDG PET/CT | Other | Other: Early interim FDG PET/CT after 1 cycle of R-CHOPSingle arm study with diagnostic imaging study as the intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CD20+ diffuse large B cell lymphoma confirmed
- Therapy naïve for lymphoma
- 19 years or older
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early interim FDG PET/CT after 1 cycle of R-CHOPFDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP | Other | Interim FDG PET/CT |
Primary outcome
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
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
3 secondary outcomes
2 year disease free survival
Time frame: 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
Quantitative response
Time frame: after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 19403881Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
- Background: PubMed 20683268Michallet AS, Trotman J, Tychyj-Pinel C. Role of early PET in the management of diffuse large B-cell lymphoma. Curr Opin Oncol. 2010 Sep;22(5):414-8. doi: 10.1097/CCO.0b013e32833d5905.
- Background: PubMed 20202462Zelenetz AD, Abramson JS, Advani RH, Andreadis CB, Byrd JC, Czuczman MS, Fayad L, Forero A, Glenn MJ, Gockerman JP, Gordon LI, Harris NL, Hoppe RT, Horwitz SM, Kaminski MS, Kim YH, Lacasce AS, Mughal TI, Nademanee A, Porcu P, Press O, Prosnitz L, Reddy N, Smith MR, Sokol L, Swinnen L, Vose JM, Wierda WG, Yahalom J, Yunus F. NCCN Clinical Practice Guidelines in Oncology: non-Hodgkin's lymphomas. J Natl Compr Canc Netw. 2010 Mar;8(3):288-334. doi: 10.6004/jnccn.2010.0021. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok-Goo Cho, MD, PhD principal investigator
The Catholic University of Korea
Joo Hyun O, MD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early interim FDG PET/CT after 1 cycle of R-CHOP in people with Lymphoma, Large B-Cell, Diffuse, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357733, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.