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

• ClinicalTrials.gov Identifier: NCT03051581
• Recruitment Status: Unknown
• First Posted: February 13, 2017
• Last Update Posted: February 13, 2017
• Sponsor: Beijing Cancer Hospital
• Collaborator: Beijing Municipal Administration of Hospitals
• Information provided by (Responsible Party): Xuejuan Wang,MD, Beijing Cancer Hospital

Tracking Information

• First Submitted Date: February 9, 2017
• First Posted Date: February 13, 2017
• Last Update Posted Date: February 13, 2017
• Estimated Study Start Date: March 1, 2017
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 9, 2017): 3 year progression-free survival [ Time Frame: up to 3 years after initial diagnosis ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Peripheral T-cell Lymphoma
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Lymphoma, T-Cell, Peripheral

Intervention

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

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2017): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03051581
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Xuejuan Wang,MD, Beijing Cancer Hospital
• Study Sponsor: Beijing Cancer Hospital
• Collaborators: Beijing Municipal Administration of Hospitals
• Investigators: Not Provided
• PRS Account: Beijing Cancer Hospital
• Verification Date: February 2017