Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral 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. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Beijing Municipal Administration of Hospitals
Information provided by (Responsible Party):
Xuejuan Wang,MD, Beijing Cancer Hospital

Tracking Information
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
 (submitted: February 9, 2017)
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
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).
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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