68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Immunotherapy; Lung Carcinoma; PET / CT

Study type: Observational

Funder types: Other

Identifiers

NCT06608160

2024-350

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
2. Pseudoprogression cannot be ruled out in clinical practice;
3. Lung cancer confirmed by pathology or cytology, regardless of pathological type;
4. Fully-informed written consent obtained from patients;
5. Patient ability to comply with protocol requirements;
6. Age 18-75 years;
7. Life expectancy of at least 6 months.

Exclusion criteria

1. 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;
2. Intestinal perforation, complete intestinal obstruction;
3. Active phase of hepatitis B；
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.