NCT06608160 68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
| NCT ID | NCT06608160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | PET / CT |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-06-20 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06608160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying PET / CT. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608160 currently recruiting?
Yes, NCT06608160 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijin Hospital to inquire about joining.
Where is the NCT06608160 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06608160 clinical trial?
NCT06608160 is sponsored by Ruijin Hospital. The trial plans to enroll 30 participants.