Cancer
Conditions
Keywords
PET/CT, Immunotherapy, Immune checkpoint inhibition, Granzyme B, 68Ga labeling
Brief summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.
Detailed description
The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.
Interventions
DRUG68Ga-grazytracer
68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.
Sponsors
Peking University Health Science Center
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who were diagnosed with malignant tumors; 2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team; 3. participants who had no prior immunotherapy; 4. participants who had no regional therapy within 3 months; 5. Participants aged ≥18 years.
Exclusion criteria
1. participants with a concurrent disease that would impede the treatment regimen; 2. Participants who were unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 68Ga-grazytracer-emergent Adverse Events | 3 year | Any adverse events following the administration of the radiotracer will be monitored. |
| Biodistribution of 68Ga-grazytracer | 3 year | The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging. |
| Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer | 3 year | The specificity of 68Ga-grazytracer will be validated by correlating the immunohistochemistry results of granzyme B in either surgical or biopsy tissue samples with the standardized uptake values (SUV) of 68Ga-grazytracer in the tumors. |
| Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response | 3 year | Participants will be categorized into groups with high or low 68Ga-grazytracer uptake in tumor lesions. The progression-free survival and treatment response, as assessed by RECIST 1.1 criteria, will be compared across these groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype | 3 year | Participants' tumors will be classified as either desert or non-desert based on immunohistochemistry staining of CD8 from tumor samples. Subsequently, the relationship between 68Ga-grazytracer uptake and the tumors' immune phenotype will be compared. |
Countries
China
Outcome results
None listed