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

October 14, 2021 updated by: Yumei Chen, RenJi Hospital

Total-body 18F-FDG PET / CT in the Evaluation of Treatment and Prognosis of Patients With Lymphoma

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Jiaotong University School of Medicine, Renji Hospital

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible patients with lymphoma will be scanned by total-body 18F-FDG uEXPLORER PET/CT

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Device: Total body PET/CT (uExplorer)
A total-body PET/CT scanner (uEXPLORER) with a 194-cm scan range will be applied in patients affected with lymphoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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.
three years after last patient recruited
OS
Time Frame: 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.
three years after last patient recruited

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Yumei Chen, Ph.D;M.D., Shanghai Jiaotong University School of Medicine, Renji Hospital

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)

October 11, 2021

Primary Completion (ANTICIPATED)

May 20, 2023

Study Completion (ANTICIPATED)

July 20, 2024

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2021-052

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

Yes

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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