68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostic performance 1
Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression
Time frame
Follow-up for 4-8 weeks, not exceeding 12 weeks.Secondary outcomes
1
Diagnostic performance 2
Investigating the optimal uptake value for 68Ga-grazytracer PET/CT imaging in diagnosing pseudoprogression.
Time frame
Follow-up for 4-8 weeks, not exceeding 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov