NCT04931875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

June 15, 2021

Last Update Submit

October 14, 2021

Conditions

Lymphoma

Keywords

Lymphoma, Total-body PET/CT, Prognosis, Dynamic Imaging

Outcome Measures

Primary Outcomes (2)

  • PFS

    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

    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

Study Arms (1)

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)

Interventions

Total body PET/CT (uExplorer)DEVICE

A total-body PET/CT scanner (uEXPLORER) with a 194-cm scan range will be applied in patients affected with lymphoma.

Total-body PET/CT (uExplorer)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (5)

  • Chen Y, Zhou M, Liu J, Huang G. Prognostic Value of Bone Marrow FDG Uptake Pattern of PET/CT in Newly Diagnosed Diffuse Large B-cell Lymphoma. J Cancer. 2018 Mar 14;9(7):1231-1238. doi: 10.7150/jca.23714. eCollection 2018.

    PMID: 29675104BACKGROUND

  • Zhou M, Chen Y, Liu J, Huang G. A predicting model of bone marrow malignant infiltration in 18F-FDG PET/CT images with increased diffuse bone marrow FDG uptake. J Cancer. 2018 Apr 19;9(10):1737-1744. doi: 10.7150/jca.24836. eCollection 2018.

    PMID: 29805699BACKGROUND

  • Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.

    PMID: 31964808BACKGROUND

  • Zhang YQ, Hu PC, Wu RZ, Gu YS, Chen SG, Yu HJ, Wang XQ, Song J, Shi HC. The image quality, lesion detectability, and acquisition time of 18F-FDG total-body PET/CT in oncological patients. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2507-2515. doi: 10.1007/s00259-020-04823-w. Epub 2020 May 18.

    PMID: 32424483BACKGROUND

  • Zhou M, Chen Y, Huang H, Zhou X, Liu J, Huang G. Prognostic value of total lesion glycolysis of baseline 18F-fluorodeoxyglucose positron emission tomography/computed tomography in diffuse large B-cell lymphoma. Oncotarget. 2016 Dec 13;7(50):83544-83553. doi: 10.18632/oncotarget.13180.

    PMID: 27835875BACKGROUND

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Yumei Chen, Ph.D;M.D.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy head of the department of nuclear medicine

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 18, 2021

Study Start

October 11, 2021

Primary Completion

May 20, 2023

Study Completion

July 20, 2024

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)