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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05113576
Other study ID # 2021-293
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2013
Est. completion date June 30, 2021

Study information

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

Clinical Trial Summary

This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)


Description:

This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL) Patients would be retrospectively includedin this study.The inclusion criteria included (1) pathologically proven DLBCL; (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin); (3) at least 2 evaluable hypermetabolic lesions on PET/CT;(4) underwent pre-treatment [18F]FDG PET/CT.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date June 30, 2021
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - (1) pathologically proven DLBCL, (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin),(3) at least 2 evaluable hypermetabolic lesions on PET/CT, (4) underwent pre-treatment [18F]FDG PET/CT Exclusion Criteria: - (1) patients who had received surgical resection or other treatments before chemotherapy, (2) patients who had coexistent central system lymphoma or other types of malignancies

Study Design


Locations

Country Name City State
China Department of Nuclear Medicine and PET/CT Center, The 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 the accuracy of prognosis prediction The accuracy of clinical model, PET models and combined model for prediction Through study completion, about 6 months
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