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Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Natural Killer/T-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03051542
Recruitment Status : Unknown
Verified February 2017 by Xuejuan Wang,MD, Beijing Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Beijing Municipal Administration of Hospitals
Information provided by (Responsible Party):
Xuejuan Wang,MD, Beijing Cancer Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease progression during chemotherapy or survival in NK/T-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma, Extranodal NK-T-Cell Device: 18F-FDG PET/CT Not Applicable

Detailed Description:
In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography / Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With NK/T-cell Lymphoma
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: NK/T-cell lymphoma patients with 18F-FDG PET/CT
18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria
 Device: 18F-FDG PET/CT
18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles [ Time Frame: baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)] ]

Secondary Outcome Measures :
  1. 3 year progression-free survival [ Time Frame: up to 3 years after initial diagnosis ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed NK/T-cell lymphoma
  • treated using an anthracycline-containing regimen
  • minimal follow-up at 6 months after the completion of first-line treatment
  • complete medical history and clinicopathological data

Exclusion Criteria:

  • secondary malignant disease
  • serious infection or inflammation (e.g., HIV)
  • primary central nervous system lymphoma
  • hepatic or renal dysfunction.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051542


Contacts
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Contact: Xuejuan Wang, MD 86 10-88196364 xuejuan_wang@hotmail.com

Locations
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China, Beijing
Peking University Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Beijing Municipal Administration of Hospitals
More Information
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Responsible Party: Xuejuan Wang,MD, Principal Investigator, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03051542    
Other Study ID Numbers: XW-NK/T-001
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuejuan Wang,MD, Beijing Cancer Hospital:
Lymphoma, Extranodal NK-T-Cell
Positron-Emission Tomography
Prognosis
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action