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68Ga-grazytracer PETCT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer a Prospective, Observational Study.
Led by Ruijin Hospital · Updated on 2024-09-23
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68Ga-grazytracer PET imaging to help diagnose pseudoprogression in lung cancer patients after immunotherapy. Pseudoprogression is difficult to distinguish with current clinical methods, which often require follow-up observations that may not meet clinical needs. This study aims to assess the effectiveness and feasibility of this novel imaging agent, which targets granzyme B to show the activity of cytotoxic T cells in tumor areas. This observational study uses 68Ga-grazytracer PETCT scans to visualize and semi-quantitatively measure granzyme B concentration in lung cancer lesions that have enlarged or developed new lesions after immune checkpoint inhibitor treatment. The study follows patients for 4-8 weeks, up to a maximum of 12 weeks, to evaluate the diagnostic performance of this imaging method in detecting pseudoprogression. Participants will undergo PETCT imaging and be monitored over the follow-up period to assess changes and outcomes. Researchers will collect data on diagnostic accuracy and safety during this time. The study includes adult lung cancer patients aged 18 to 75 years who meet specific clinical criteria and have a life expectancy of at least six months. Total participation duration varies with the follow-up period, and patient compliance with study requirements is monitored throughout.
CONDITIONS
Brief Title
68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lung cancer patients who develop 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 will not qualify if you...
- Patients with serious diseases deemed unsuitable for participation, such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency
- Intestinal perforation or complete intestinal obstruction
- Active phase of hepatitis B
- Pregnant women, women who are potentially pregnant, and nursing mothers
- Patients with poor compliance
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