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

NCT ID: NCT03051581

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-12-31

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.

Conditions

Lymphoma, T-Cell, Peripheral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F-FDG PET/ CT

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Xuejuan Wang,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xuejuan Wang, MD

Role: CONTACT

xuejuan_wang@hotmail.com

86 10-88196364

Other Identifiers

XW-PTCL-002

Identifier Type: -

Identifier Source: org_study_id