Clinical trial · Interventional
PD-L1 Specific [68Ga]Ga-THP-PDL1-3 Probe for PET Imaging in Solid Tumors
A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
To utilize the \[68Ga\]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| [68Ga]Ga-THP-PDL1-3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-THP-PDL1-3
- description
- All study participants will be allocated to this arm (single-arm study).Study participants will undergo \[68Ga\]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of \[68Ga\]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection.
- interventionNames
- Drug: 18F-FDG
- Drug: [68Ga]Ga-THP-PDL1-3
Primary outcomes (1)
- measure
- Safety and Feasibility
- timeFrame
- 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
- description
- 1. Adverse Event Number of participants with tracer-related adverse events. 2. Feasibility of PET/CT Imaging Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by a senior nuclear medicine physician. Images were considered evaluable if they met diagnostic quality criteria. 3. Quality Control Standards for the Radiotracer Radiochemical purity ≥95% (determined by iTLC); Sterility (tested by the direct inoculation method according to pharmacopoeial standards); Bacterial endotoxins ≤15 EU/mL (as determined by photometry). 4. Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder. Safety and feasibility were evaluated by no adverse events after comprehensive indicators.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years, ECOG score 0 or 1; 2. Patients with solid tumors; 3. Presence of measurable lesions on imaging examinations; 4. Expected survival ≥12 weeks. Exclusion Criteria: 1. Severe hepatic or renal dysfunction; 2. Women who are planning pregnancy, pregnant, or breastfeeding; 3. Unable to remain in supine position for 30 minutes; 4. Refusal to participate in this clinical study; 5. Diagnosis of claustrophobia or other psychiatric disorders; 6. Other conditions deemed by the investigator as inappropriate for participation in the trial.
References
Publications (0)
Data not yet available