⁶⁸Ga-DPA in the Lung Cancer Diagnosis
Clinical Application of PD-L1 Targeted Imaging Agent ⁶⁸Ga-DPA in the Diagnosis of Lung Cancer
1 other identifier
interventional
40
1 country
1
Brief Summary
In previous studies, we synthesized a PD-L1-targeted molecular probe, ⁶⁸Ga-DPA, and developed a ⁶⁸Ga-DPA injection for clinical research. Preliminary studies demonstrated its favorable safety profile and excellent imaging performance. Leveraging the established strengths of the Department of Nuclear Medicine at Peking Union Medical College Hospital, we now plan to conduct an exploratory PET/CT imaging study in lung cancer patients. This study aims to provide an in vivo, non-invasive, and visualizable technique for detecting PD-L1 expression levels and spatial distribution in tumors. It will further validate the clinical utility of this technology, offering critical diagnostic insights for initial assessment and treatment efficacy evaluation in PD-L1-positive tumor patients undergoing PD-L1-targeted therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2024
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2024
CompletedFirst Submitted
Initial submission to the registry
June 8, 2025
CompletedFirst Posted
Study publicly available on registry
June 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 28, 2027
June 15, 2025
June 1, 2025
2 years
June 8, 2025
June 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SUV
measured by PET/CT
0-180 minutes post-injection
Study Arms (1)
68Ga-DPA PEWT/CT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years, regardless of gender.
- Patients clinically confirmed or suspected of lung cancer, with pathological specimens obtainable via biopsy or surgery within the recent 2 months.
- At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Expected survival \>3 months.
You may not qualify if:
- Severe hepatic or renal dysfunction (serum creatinine \>3.0 mg/dL or any liver enzyme level ≥5× upper limit of normal).
- Women who are planning pregnancy, pregnant, or breastfeeding.
- Inability to lie supine for 30 minutes.
- Claustrophobia or other psychiatric disorders.
- Intolerance to any clinical procedures in the study.
- Other conditions deemed ineligible by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
100730
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2025
First Posted
June 15, 2025
Study Start
September 28, 2024
Primary Completion (Estimated)
September 28, 2026
Study Completion (Estimated)
September 28, 2027
Last Updated
June 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share