Lung CancersEarly Phase 1NCT07023068
⁶⁸Ga-DPA in the Lung Cancer Diagnosis
A Early Phase 1 study testing 68Ga-DPA PET/CT in people with Lung Cancers, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancers
- What is being tested?
- 68Ga-DPA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2024to 28 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Application of PD-L1 Targeted Imaging Agent ⁶⁸Ga-DPA in the Diagnosis of Lung Cancer
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.
- Conditions
- Lung Cancers
- Being tested
- 68Ga-DPA PET/CT
- Keywords
- PD-L1, lung cancer, PET/CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DPA PET/CTDiagnostic test
Use 68Ga-DPA PET/CT in the diagnosis of lung cancer
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DPA PEWT/CT | Experimental | Not described Receives: Diagnostic Test: 68Ga-DPA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
measured by PET/CT
Measured: 0-180 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start28 Sep 2024
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023068
- Sponsor's protocol ID
- PUMCH-PDL1
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of PD-L1 Targeted Imaging Agent ⁶⁸Ga-DPA in the Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT07023068
- Acronym / sponsor ID
- PUMCH-PDL1
- Conditions
- Lung Cancers
- Keywords
- PD-L1, lung cancer, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DPA PEWT/CT | Experimental | Diagnostic Test: 68Ga-DPA PET/CT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DPA PET/CTUse 68Ga-DPA PET/CT in the diagnosis of lung cancer | Diagnostic test | 68Ga-DPA PEWT/CT |
Primary outcome
SUV
Time frame: 0-180 minutes post-injection
measured by PET/CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaohui Zhu principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-DPA PET/CT in people with Lung Cancers, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 0-180 minutes post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.