Using 68Ga-grazytracer PET to diagnose pseudoprogression in lung cancer after immunotherapy.
68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.
This study is testing a new type of PET scan to see if it can help doctors tell the difference between real tumor growth and temporary swelling in lung cancer patients after they receive immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06608160 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of 68Ga-grazytracer PET imaging in diagnosing pseudoprogression in lung cancer patients who have undergone immunotherapy. Pseudoprogression is a condition where tumor enlargement occurs due to immune response rather than actual tumor growth, making it challenging to assess treatment efficacy. The study will utilize a novel imaging agent that targets granzyme B, reflecting the presence of cytotoxic T cells in the tumor area. By leveraging the advantages of this imaging technique, the study seeks to provide a more accurate diagnosis for patients experiencing lesion changes post-treatment.
Who should consider this trial
Good fit: Ideal candidates include lung cancer patients aged 18-75 who exhibit lesion enlargement or new lesions after treatment with immune checkpoint inhibitors.
Not a fit: Patients with serious comorbidities or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for lung cancer patients undergoing immunotherapy, allowing for better treatment decisions.
How similar studies have performed: While there is limited data on the specific use of 68Ga-grazytracer PET for this purpose, the approach of using novel imaging agents in cancer diagnostics has shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.