Clinical trial · Interventional
68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy
68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma
NCT05000372CI-TRIAL-00083318completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-grazytracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Feasibility and safety of 68Ga-grazytracer
- description
- The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.
- interventionNames
- Drug: 68Ga-grazytracer
Primary outcomes (4)
- measure
- Incidence of 68Ga-grazytracer-emergent Adverse Events
- timeFrame
- 3 year
- description
- Any adverse events following the administration of the radiotracer will be monitored.
- measure
- Biodistribution of 68Ga-grazytracer
- timeFrame
- 3 year
- description
- The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants who were diagnosed with malignant tumors; 2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team; 3. participants who had no prior immunotherapy; 4. participants who had no regional therapy within 3 months; 5. Participants aged ≥18 years. Exclusion Criteria: 1. participants with a concurrent disease that would impede the treatment regimen; 2. Participants who were unable or unwilling to provide written informed consent.
References
Publications (2)
- DERIVEDShen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2. PMID 39389969
- DERIVEDZhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065. PMID 35788116