18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
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ClinicalTrials.gov Identifier: NCT03051581 |
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
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Sponsor:
Beijing Cancer Hospital
Collaborator:
Beijing Municipal Administration of Hospitals
Information provided by (Responsible Party):
Xuejuan Wang,MD, Beijing Cancer Hospital
Tracking Information | |||||
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First Submitted Date ICMJE | February 9, 2017 | ||||
First Posted Date ICMJE | February 13, 2017 | ||||
Last Update Posted Date | February 13, 2017 | ||||
Estimated Study Start Date ICMJE | March 1, 2017 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
3 year progression-free survival [ Time Frame: up to 3 years after initial diagnosis ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma | ||||
Official Title ICMJE | 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma | ||||
Brief Summary | The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of PTCL can predict disease progression | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Lymphoma, T-Cell, Peripheral | ||||
Intervention ICMJE | 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).
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Study Arms ICMJE | 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.
Intervention: Device: 18F-FDG PET/ CT
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 80 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03051581 | ||||
Other Study ID Numbers ICMJE | XW-PTCL-002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xuejuan Wang,MD, Beijing Cancer Hospital | ||||
Study Sponsor ICMJE | Beijing Cancer Hospital | ||||
Collaborators ICMJE | Beijing Municipal Administration of Hospitals | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Beijing Cancer Hospital | ||||
Verification Date | February 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |