PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells
PET / CT Imaging and Safety of the 68Ga-NOTA-RP25 Molecular Probe in Patients With Lymphoma Who Have Received Prior Therapy Containing CD19 CAR-T Cells
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lymphoma
Started Jan 2022
Shorter than P25 for not_applicable lymphoma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 4, 2022
December 1, 2021
11 months
December 3, 2021
December 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
SUV value of radioactive material uptake in the region of interest
According to the PET / CT imaging results of 68Ga-NOTA-RP25 after iterative reconstruction, PMOD software is used to outline the tumor, brain, liver, heart, tumor and other tissues as regions of interest (ROI)
1 month
Secondary Outcomes (1)
Safety evaluation index
1 month
Study Arms (1)
68Ga-NOTA-RP25
EXPERIMENTALIntravenous injection
Interventions
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25
Eligibility Criteria
You may qualify if:
- \. The subjects voluntarily signed the informed consent form and were able to complete the test according to the protocol requirements; 2. Over 18 years old, male or female; 3. Diagnosed as lymphoma and intended to receive CD19 car-t treatment; 4. ECOG score is 0-1; The estimated survival time shall not be less than 3 months;
You may not qualify if:
- \. Participate in other clinical trials other than CAR-T treatment at the same time or within 28 days. If participating in a non intervention clinical trial, it can be included in this study; 2. Patients with a history of allergy; 3. Patients who cannot tolerant PET / CT imaging； 4. Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liyan Miao
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Pharmacist
Study Record Dates
First Submitted
December 3, 2021
First Posted
January 4, 2022
Study Start
January 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 4, 2022
Record last verified: 2021-12