18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma

Not Applicable

• Conditions: Lymphoma, Large B-Cell, Diffuse
• Interventions: Device: 18F-FDG PET/CT

• Registration Number: NCT02928861
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of diffuse large B-cell lymphoma 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 (1.6 fold of liver SUVmax) 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 DLBCL.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. newly diagnosed DLBCL;
2. treated using an anthracycline-containing regimen with or without rituximab;
3. minimal follow-up at 6 months after the completion of first-line treatment;
4. complete medical history and clinicopathological data

Exclusion Criteria

1. secondary malignant disease;
2. serious infection or inflammation (e.g., HIV);
3. primary central nervous system lymphoma;
4. hepatic or renal dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG PET/CT-based prognostic model	18F-FDG PET/CT	The new prognostic model is based on 18F-FDG PET/CT scans, and combined with clinical and pathological prognostic factors.

Primary Outcome Measures

Name	Time	Method
2 year progression-free survival	up to 2 years after initial diagnosis

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, China