Total-body PET / CT in the Evaluation of Treatment and Prognosis of Lymphoma

• Conditions: Lymphoma
• Interventions: Device: Total body PET/CT (uExplorer)

• Registration Number: NCT04931875
• Lead Sponsor: RenJi Hospital

Brief Summary

The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing the treatments and prognosis in patients affected with lymphoma. Total-body 18F-FDG PET/CT scans are being performed before treatment, after three cycles of chemotherapy and six weeks after the end of treatment. The plan of this study involves to evaluate the clinical application of total-body PET / CT in patients histopathologically-diagnosed as lymphoma, and to optimize the dynamic acquisition protocols with total-body 18F-FDG PET/CT.

Detailed Description

100 cases of lymphoma patients are enrolled in this study. Participation in this study involves three dynamic 18F-FDG PET/CT exams, which occur before the treatments start, two or three days before the fourth cycle of chemotherapy, and then six weeks after the end of last treatments. Progress Free Survival(PFS) and Overall Survival(OS) are used as the end points to study the value of metabolic parameters obtained from the dynamic PET/CT imaging. The differences of dynamic metabolic parameters and static SUV value are evaluated in patients with lymphoma from the perspective of diagnosis, staging, treatment and prognosis.

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Status Verified: 2021-10
• Study Start: 2021-10-11
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15
• Primary Completion: 2023-05-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Had histologically confirmed lymphoma
• Patients aged 18~75 years old

Exclusion Criteria

• Female patients who are pregnant, breast-feeding
• Currently active second malignancy other than Lymphoma
• Any situation not suitable for this study judged by researchers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total-body PET/CT (uExplorer)	Total body PET/CT (uExplorer)	The diagnostic value of dynamic parameters(K1、Ki etc) to evaluate the prognosis of lymphoma compared to the static ones(SUV、MTV、TLG etc).

Primary Outcome Measures

Name	Time	Method
OS	three years after last patient recruited	The duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
PFS	three years after last patient recruited	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

Trial Locations

Locations (1)

Shanghai jiaotong University School of Medicine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China