18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of PTCL can predict disease progression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 13, 2017
February 1, 2017
2.8 years
February 9, 2017
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3 year progression-free survival
up to 3 years after initial diagnosis
Study Arms (1)
18F-FDG PET/CT-based prognostic model of PTCL
EXPERIMENTALThe new prognostic model is based on 18F-FDG PET/ CT scans, and combined with clinical and pathological prognostic factors.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- secondary malignant disease
- serious infection or inflammation (e.g., HIV)
- primary central nervous system lymphoma
- hepatic or renal dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 13, 2017
Study Start
March 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share