18F-FDG PET Radiomics of Diffuse Large B-cell Lymphoma

Completed

• Conditions: Lymphoma, Large B-Cell, Diffuse

• Registration Number: NCT04317313
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This study aims to investigate the prognostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) radiomics in diffuse large B-cell lymphoma (DLBCL) and its additional value to the International Prognostic Index (IPI).

Detailed Description

Several studies have shown that 18F-FDG PET radiomics is predictive of survival in DLBCL. However, to the best of the investigator's knowledge, a multi-feature radiomic signature for prognosis assessment of DLBCL has not yet been described. Furthermore, it remains unclear whether PET-based radiomics could add more prognostic values to the IPI in DLBCL.

This study aims to develop 18F-FDG PET radiomic signature, and investigate whether the radiomic signature could improve the prognostic value of the IPI score in predicting progression-free survival (PFS) and overall survival (OS) in DLBCL.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Study Start: 2020-04-01
• Status Verified: 2021-05
• Results First Submitted: 2021-05-09
• Results First Submitted QC: 2021-06-03
• Results First Posted: 2021-06-25
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. histopathologically confirmed diffuse large B-cell lymphoma (DLBCL);
2. Over 18 years old when diagnosed;
3. Have undergone pre-treatment 18F-FDG PET/CT;
4. Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).

Exclusion Criteria

1. Have primary central nervous system (CNS) lymphoma or second primary cancer;
2. Have undergone surgical resection;
3. With an incomplete follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years	the period from the initial diagnosis to the death from any cause
Progression-free Survival	From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years	the period from the initial diagnosis to the progression, relapse or death from any cause

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China