Actively Recruiting
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
Led by Ruijin Hospital · Updated on 2025-01-01
40
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68Ga-grazytracer PET/CT imaging to assess early responses to neoadjuvant immunotherapy in patients with resectable non-small cell lung cancer (NSCLC) stages IB to IIIA. The study aims to improve noninvasive methods for determining how cancer responds to immunotherapy before surgery. This observational study involves patients who have been clinically staged and meet specific eligibility criteria, including age and health status. Participants receive standardized neoadjuvant immunotherapy every three weeks for three cycles. Patients with nonsquamous NSCLC are treated with pembrolizumab combined with platinum-pemetrexed, while those with squamous NSCLC receive pembrolizumab plus platinum-paclitaxel. 68Ga-grazytracer PET/CT scans are performed twice: once before treatment begins and again before the third cycle to monitor immune response. During the study, patients will undergo imaging assessments along with pathological evaluations after surgery to determine major pathological response within three weeks post-operation. Researchers focus on comparing imaging responses and PET/CT results to the pathological findings. The study also monitors participants' performance status and survival expectations, with informed consent obtained before enrollment. The total study duration extends through treatment, surgery, and follow-up assessments to evaluate treatment effects comprehensively.
CONDITIONS
Brief Title
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical stage IB to IIIA non-small cell lung cancer confirmed before treatment
- Confirmation by an experienced surgeon that the cancer can be removed by surgery
- Histological diagnosis of primary non-small cell lung cancer
- Men and women aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Expected survival of at least 6 months
- Signed informed consent form
You will not qualify if you...
- Diagnosis other than non-small cell lung cancer
- Lung cancer that cannot be surgically removed or has distant metastasis
- Previous malignancies unless completely in remission for at least 2 years without further therapy
- Active or history of autoimmune diseases or immunodeficiency such as HIV or active hepatitis
- Uncontrolled diabetes with fasting blood glucose of 11.0 mmol/L or higher on test day
- Women who are pregnant or breastfeeding
- History of severe cardiovascular disease, severe myelosuppression, or severe liver and kidney failure
- History of allogeneic organ or stem cell transplantation
- Any medical, mental, or psychological condition that would prevent study completion or understanding of study information
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will be assessed for inclusion, including verification of clinical stage and eligibility
Duration - Approximately 6 weeks during neoadjuvant immunotherapy
Participants undergo 68Ga-grazytracer PET/CT imaging to evaluate the early response to neoadjuvant immunotherapy in non-small cell lung cancer.
2 imaging visits (at baseline and before the third treatment cycle)
Duration - Up to 3 weeks after surgery
Participants are assessed for pathological response after surgery and monitored for treatment outcomes.
1 visit to assess major pathological response after surgery
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hecheng Li, MD, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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