Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients
NCT ID: NCT01357733
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
53 participants
INTERVENTIONAL
2012-03-02
2023-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Interim FDG PET/CT
Single arm study with diagnostic imaging study as the intervention.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Therapy naïve for lymphoma
* 19 years or older
* Written informed consent
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Sung Hoon Kim
Chairman of Department of Radiology
Principal Investigators
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Seok-Goo Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Joo Hyun O, MD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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References
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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.
Michallet 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.
Zelenetz 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.
Other Identifiers
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KC11EISI0293
Identifier Type: -
Identifier Source: org_study_id
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