The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer

The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer: a Prospective, Observationa Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06623487

Enrollment

Registered

2024-10-02

Start date

2024-07-19

Completion date

2027-07-31

Last updated

2024-10-02

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

Conditions

Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy, PET / CT

Brief summary

Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.

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. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy; 2. Fully-informed written consent obtained from patients; 3. Patient ability to comply with protocol requirements; 4. Age 18-75 years; 5. 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. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test; 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
Predictive performance 1	up to the end of surgery	Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.

Secondary

Measure	Time frame	Description
Predictive performance 2	3 years	Assessing the predictive value of 68Ga-grazytracer PET for adjuvant immunotherapy efficacy after surgery, as measured by disease-free survival

Countries

China

Outcome results