68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
Recruiting now
Conditions studied: PET / CT, Lung Carcinoma, Immunotherapy
In brief
Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.
Key facts
- Study ID
- NCT06608160
- Run by
- Ruijin Hospital
- People needed
- 30
- Starts
- 2024-06-20
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-09-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
- Pseudoprogression cannot be ruled out in clinical practice;
- Lung cancer confirmed by pathology or cytology, regardless of pathological type;
- Fully-informed written consent obtained from patients;
- Patient ability to comply with protocol requirements;
- Age 18-75 years;
- Life expectancy of at least 6 months.
You may not qualify if…
- Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
- Intestinal perforation, complete intestinal obstruction;
- Active phase of hepatitis B；
- Pregnant women and women who are potentially pregnant, as well as nursing mothers;
- Patients with poor compliance.
Where it is running
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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