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

Sponsor
RenJi Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04931875
Collaborator
(none)
100
1
33.3
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Total body PET/CT (uExplorer)

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Total-body 18F-FDG PET / CT in the Evaluation of Treatment and Prognosis of Patients With Lymphoma
Actual Study Start Date :
Oct 11, 2021
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
Jul 20, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yumei Chen, deputy head of the department of nuclear medicine, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT04931875
Other Study ID Numbers:
  • KY2021-052
First Posted:
Jun 18, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Yumei Chen, deputy head of the department of nuclear medicine, RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021