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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05176275

Enrollment

Registered

2022-01-04

Start date

2022-01-01

Completion date

2022-12-01

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

Interventions

DIAGNOSTIC_TEST68Ga-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
SUV value of radioactive material uptake in the region of interest	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)

Secondary

Measure	Time frame	Description
Safety evaluation index	1 month	To observe AE/SAE of subjects

Contacts

Primary ContactHua Zhang

sdfyy8040@126.com86 0512 6797 2858

Backup ContactYicong Bian

bianyicong@126.com86 0512 6797 2858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026