⁶⁸Ga-DPA in the Lung Cancer Diagnosis

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.

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Key information

Conditions

Lung Cancers Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

100730

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

68Ga-DPA PET/CT

Diagnostic Test

Use 68Ga-DPA PET/CT in the diagnosis of lung cancer

Primary outcomes

SUV

Time frame: 0-180 minutes post-injection

measured by PET/CT

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Clinical Application of PD-L1 Targeted Imaging Agent ⁶⁸Ga-DPA in the Diagnosis of Lung Cancer

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jun 15, 2025
Registry last updated: Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed