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

68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06608160

Enrollment

Registered

2024-09-23

Start date

2024-06-20

Completion date

2025-12-31

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy, Lung Carcinoma, PET / CT

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance 1	Follow-up for 4-8 weeks, not exceeding 12 weeks.	Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression

Secondary

Measure	Time frame	Description
Diagnostic performance 2	Follow-up for 4-8 weeks, not exceeding 12 weeks.	Investigating the optimal uptake value for 68Ga-grazytracer PET/CT imaging in diagnosing pseudoprogression.

Countries

China

Outcome results