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

NCT ID: NCT04931875

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-11

Study Completion Date

2024-07-20

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Total body PET/CT (uExplorer)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yumei Chen

deputy head of the department of nuclear medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yumei Chen, Ph.D;M.D.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29675104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29805699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31964808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32424483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27835875 (View on PubMed)

Other Identifiers

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KY2021-052

Identifier Type: -

Identifier Source: org_study_id