Back to resultsPET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells
Primary Purpose
Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
68Ga-NOTA-RP25
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 1. 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;
Exclusion Criteria:
- 1. 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-NOTA-RP25
Arm Description
Intravenous injection
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Safety evaluation index
To observe AE/SAE of subjects
Full Information
NCT ID
NCT05176275
First Posted
December 3, 2021
Last Updated
December 16, 2021
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05176275
Brief Title
PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.
Detailed Description
The purpose of this study is to monitor the proliferation and distribution of CD19 CAR-T cells in lymphoma patients by using a novel specific PET tracer 68Ga-NOTA-RP25 for monitoring the proliferation of CAR-T cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-NOTA-RP25
Arm Type
Experimental
Arm Description
Intravenous injection
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-NOTA-RP25
Intervention Description
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25
Primary Outcome Measure Information:
Title
SUV value of radioactive material uptake in the region of interest
Description
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)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Safety evaluation index
Description
To observe AE/SAE of subjects
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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;
Exclusion Criteria:
1. 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhang
Phone
86 0512 6797 2858
Email
sdfyy8040@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yicong Bian
Phone
86 0512 6797 2858
Email
bianyicong@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyan Miao
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells
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