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

NCT04317313 | Completed Results

• 1 other identifier: 2019-350
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

FDG PET radiomic feature evaluation OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target study population of this retrospective study is patients with DLBCL who have undergone pre-treatment 18F-FDG PET/CT prior to the R-CHOP or R-EPOCH chemotherapy. The study will assess the relationships between PET-derived radiomic features with the patient outcome data.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Zhang X, Chen L, Jiang H, He X, Feng L, Ni M, Ma M, Wang J, Zhang T, Wu S, Zhou R, Jin C, Zhang K, Qian W, Chen Z, Zhuo C, Zhang H, Tian M. A novel analytic approach for outcome prediction in diffuse large B-cell lymphoma by [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1298-1310. doi: 10.1007/s00259-021-05572-0. Epub 2021 Oct 15.

  PMID: 34651227 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Xiaohui Zhang
• Organization: Second Affiliated Hospital, School of Medicine, Zhejiang University

zhanghui4127@zju.edu.cn

+86-571-87767188

Study Officials

• Mei Tian, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 23, 2020
• Study Start: April 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 21, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)