Clinical trial NCT04317313: 18F-FDG PET Radiomics of Diffuse Large B-cell Lymphoma
Official title: Synergistic Effect of 18F-FDG PET Radiomics and International Prognostic Index on Outcome Prediction in Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
measure: Progression-free Survival
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Mei Tian, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.