68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PET / CT, Lung Carcinoma, Immunotherapy. 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 →
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Official title
68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.
Overview
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.
Primary outcome measures
- Diagnostic performance 1 [Time frame: Follow-up for 4-8 weeks, not exceeding 12 weeks.]
Secondary outcome measures (1)
- Diagnostic performance 2 [Time frame: Follow-up for 4-8 weeks, not exceeding 12 weeks.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06608160 · 2024-350