- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03051581
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
February 9, 2017 updated by: Xuejuan Wang,MD, Peking University Cancer Hospital & Institute
The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of PTCL can predict disease progression
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 PTCL.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Peking University Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- newly diagnosed PTCL
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-FDG PET/CT-based prognostic model of PTCL
The new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3 year progression-free survival
Time Frame: up to 3 years after initial diagnosis
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up to 3 years after initial diagnosis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2017
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 9, 2017
First Posted (Actual)
February 13, 2017
Study Record Updates
Last Update Posted (Actual)
February 13, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- XW-PTCL-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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