Clinical trial · Observational
The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy
NCT07039474CI-TRIAL-00091420recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Cancer | — | UNRESOLVED | — |
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor Malignancies | — | UNRESOLVED | — |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-G1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Number of participants with 18F-G1-related adverse events (AEs).
- timeFrame
- 3 days after the injection of 18F-G1
- description
- The absolute number of participants with AEs after the injection of 18F-G1 according to CTCAE 5.0.
- measure
- Tumor uptake of 18F-G1
- timeFrame
- 40-60 minutes after the injection of 18F-G1
- description
- The uptake of 18F-G1 in tumors will be quantitatively assessed by SUVmax.
- measure
- Liver uptake of 18F-G1
- timeFrame
- 40-60 minutes after the injection of 18F-G1
- description
- The uptake of 18F-G1 in liver will be quantitatively assessed by SUVmax.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects diagnosed with a malignant tumor by histopathology who are going to receive immunotherapy (monotherapy or combined immunotherapy) recommended by the multidisciplinary team. 2. Subjects didn't receive previous immunotherapy. 3. There exists at least one measurable target lesion according to the RECIST 1.1. 4. ECOG performance status≤2. 5. The expected survival time is ≥6 months. 6. Effective contraceptive measures will be adopted during the study period and within 6 months after the study. 7. Willing and able to fully understand and sign the informed consent form. Exclusion Criteria: 1. Women in the preconception period, pregnancy, or lactation period. 2. Combined with other malignant tumor. 3. Diagnosed with autoimmune disease, or have long history of systemic steroid hormone therapy or immunosuppressive therapy. 4. Having a history of severe cardiovascular disease, severe hepatic and renal insufficiency. 5. Receiving radiotherapy or interventional therapy during the immunotherapy. 6. 18F-G1 PET/CT or 18F-FDG PET/CT is not performed in our department, or the interval between baseline imaging and immunotherapy is more than 30 days.
References
Publications (0)
Data not yet available
No reference posted for this study.