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18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051555
Recruitment Status : 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

Brief Summary:
The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma can predict disease progression

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

Detailed Description:
In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/ CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma.

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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: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/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

Arm Intervention/treatment
Experimental: 18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma
The new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors.
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 (8-10min/bed).




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


Information from the National Library of Medicine

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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.

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): NCT03051555


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
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Responsible Party: Xuejuan Wang,MD, Principal Investigator, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03051555    
Other Study ID Numbers: XW-NK/T-002
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