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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

Synergistic Effect of 18F-FDG PET Radiomics and International Prognostic Index on Outcome Prediction in Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317313
• Other study ID #: 2019-350
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• FDG PET radiomic feature evaluation
A total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features. In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	the period from the initial diagnosis to the death from any cause	From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
Primary	Progression-free Survival	the period from the initial diagnosis to the progression, relapse or death from any cause	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