Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| PET / CT | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance 1
- timeFrame
- Follow-up for 4-8 weeks, not exceeding 12 weeks.
- description
- Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression
Secondary outcomes (1)
- measure
- Diagnostic performance 2
- timeFrame
- Follow-up for 4-8 weeks, not exceeding 12 weeks.
- description
- Investigating the optimal uptake value for 68Ga-grazytracer PET/CT imaging in diagnosing pseudoprogression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available