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

September 27, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
Progression-free Survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Mei Tian, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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