PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells

December 16, 2021 updated by: Miao Liyan, The First Affiliated Hospital of Soochow University

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

The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-NOTA-RP25
Intravenous injection
Diagnostic test: 68Ga-NOTA-RP25
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV value of radioactive material uptake in the region of interest
Time Frame: 1 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation index
Time Frame: 1 month
To observe AE/SAE of subjects
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: LiYan Miao, The First Affiliated Hospital of Soochow University

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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstSoochoowU

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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