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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04931875
• Other study ID #: KY2021-052
• Status: Enrolling by invitation
• Start date: October 11, 2021
• Est. completion date: July 20, 2024

Study information

• Verified date: October 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 20, 2024
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View 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 (18)F-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. — View 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. — View Citation

Zhou M, Chen Y, Liu J, Huang G. A predicting model of bone marrow malignant infiltration in (18)F-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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