Cancer
Conditions
Brief summary
This is an open-label PET/CT study to investigate the safety and clinical monitoring value of 18F-grazy-02 in patients with lymphoma or solid tumors receiving immunotherapy, including immune checkpoint inhibition and CAR-T cell therapy.
Interventions
DRUG18F-grazy-02
18F-grazy-02 PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 18F-grazy-02 , a Total-body PET/CT uEXPLORER scanner will be applied.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-75 years old; 2. ECOG score 0 or 1 point; 3. Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.
Exclusion criteria
1. Pregnant or nursing; 2. Severe hepatic or renal dysfunction; 3. Low WBC (less than 3 x 10\^9/L); 4. Unable to comply with the PET/CT imaging procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 18F-grazy-02-emergent Adverse Events | 1 year | Any adverse events following the administration of the radiotracer will be monitored. |
| Biodistribution of 18F-grazy-02 in participants | 1 year | The distribution of 18F-grazy-02 in tumors and healthy tissues will be examined through PET/CT imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing 18F-grazy-02 PET for monitoring immunotherapy responses | 3 years | Participants will be categorized into groups with high or low 18F-grazy-02 uptake in tumor lesions. Therapy efficacy of immunotherapy as assessed by RECIST 1.1 will be compared across these two groups. |
Countries
China
Contacts
CONTACTLinyu Zhang
Outcome results
None listed