Clincosm LogoSign in Get a demo

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

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05176275
Collaborator
(none)
10
Enrollment
1
Arm
11
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga-NOTA-RP25
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Safety evaluation index [1 month]

    To observe AE/SAE of subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
  1. 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 imagingļ¼› 4. Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital of Soochow University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miao Liyan, Chief Pharmacist, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT05176275
Other Study ID Numbers:
  • FirstSoochoowU
First Posted:
Jan 4, 2022
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Jan 4, 2022