Clinical trial NCT04931875: Total-body PET / CT in the Evaluation of Treatment and Prognosis of Lymphoma
Official title: Total-body 18F-FDG PET / CT in the Evaluation of Treatment and Prognosis of Patients With Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Keywords: Lymphoma, Total-body PET/CT, Prognosis, Dynamic Imaging
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients with lymphoma will be scanned by total-body 18F-FDG uEXPLORER PET/CT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: three years after last patient recruited
measure: OS
timeFrame: three years after last patient recruited
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiaotong University School of Medicine,Renji Hospital
name: Yumei Chen, Ph.D;M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.