- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05004961
The Performance of Multi-tracer Multimodality PET in Lymphoma
March 2, 2023 updated by: Xuejuan Wang, Peking University Cancer Hospital & Institute
Investigating the performance of Multi-tracer Multimodality PET in lymphoma
Study Overview
Status
Recruiting
Conditions
Detailed Description
In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by different molecular probe such as FDG, FAPI-04 via multimodality PET (PET/CT and PET/MR).
Our Previous studies have shown that uptake of FAPI-04 on PET may be an indicator of lymphoma lesions.
The combination of PET with CT/MR allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Peking University Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients pathologically diagnosed as lymphoma
Description
Inclusion Criteria:
- pathologically diagnosed as lymphoma;
- Written informed consent for receiving FAPI-04 PET examinations.
- cancer planned chemotherapy or immunotherapy scheme.
- expected survival ≥ 12 weeks
Exclusion Criteria:
- cannot lie supine for half an hour;
- refuse to join the clinical researcher;
- severe liver or kidney dysfunction
- pregnancy or lactation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SUVmax
Time Frame: 150 days
|
Standardized uptake value of 68Ga/ 18F-NOTA-FAPI 04 for target lesion of subject or suspected tumor in each time point window (SUV)
|
150 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yang Zhi, PhD, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Anticipated)
August 15, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
August 7, 2021
First Submitted That Met QC Criteria
August 7, 2021
First Posted (Actual)
August 13, 2021
Study Record Updates
Last Update Posted (Estimate)
March 3, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XW-MMPET-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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