PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma

Recruiting

• Conditions: Diffuse Large B-Cell Lymphoma

• Registration Number: NCT06755775
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.

Detailed Description

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy (CAR-T, Glofitamab or iR2 ).

Study Timeline

• Study Start: 2024-07-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2029-07-23
• Study Completion: 2029-07-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Pathologic diagnosis of DLBCL
2. Patient's general condition is good and survival is expected to be greater than six months
3. Signed and dated informed consent form

Exclusion Criteria

1. Combined with other malignant tumors
2. Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
3. Pregnant women and women at risk of pregnancy, breastfeeding women
4. poor compliant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma	Baseline and 2 weeks after treatment	The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma
Standardized uptake value (SUV)	Baseline and 2 weeks after treatment	SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions

Secondary Outcome Measures

Name	Time	Method
Progress free suivival	3 years	Progress free suivival
Overall survival	3 years	Overall survival

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School; 🇨🇳 Shanghai, China