Recruiting NCT07724535
18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-grazy-02.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy in Patients With Lymphoma or Solid Tumors
Overview
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
- Drug 18F-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.
Primary outcome measures
- Incidence of 18F-grazy-02-emergent Adverse Events [Time frame: 1 year]
- Biodistribution of 18F-grazy-02 in participants [Time frame: 1 year]
Secondary outcome measures (1)
- Assessing 18F-grazy-02 PET for monitoring immunotherapy responses [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 18-75 years old;
- ECOG score 0 or 1 point;
- 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
- Pregnant or nursing;
- Severe hepatic or renal dysfunction;
- Low WBC (less than 3 x 10\^9/L);
- Unable to comply with the PET/CT imaging procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University Cancer Hospital & Institute — Beijing
Identifiers
NCT: NCT07724535 · 2021KT86-ZY01