Breast CancerEarly Phase 1NCT06411678
Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
A Early Phase 1 study testing 68GA-DOTA-dPNE in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 68GA-DOTA-dPNE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 31 Dec 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years with an expected survival of at least 12 weeks No prior radiotherapy or chemotherapy; surgery or biopsy is feasible for pathological diagnosis At least one measurable target lesion as defined by RECIST v1.1 Able to provide written informed consent and comply with follow-up requirements
Who cannot join
- Severe hepatic or renal dysfunction Pregnant, breastfeeding, planning to become pregnant, or planning to have children during the study period; women of childbearing potential must use effective contraception during the study Unable to lie flat for 30 minutes History of claustrophobia or other psychiatric disorders Any other condition deemed unsuitable for participation by the investigator Refusal to participate in the clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PUMCH
Dongcheng, Beijing Municipality, 100730
Chenhao JIA, 18548703382, jiachenhao24@163.com
About this study
The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. As part of the study design, a subset of patients will initially undergo dynamic PET/CT imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. Subsequently, static PET/CT imaging will be performed on additional patients to assess the diagnostic effectiveness of 68Ga-DOTA-dPNE. Imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.
- Conditions
- Breast Cancer
- Being tested
- 68GA-DOTA-dPNE
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68GA-DOTA-dPNEDrug
Patients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after 40min of injection
| Study group | Role | What they receive |
|---|---|---|
| 68GA-DOTA-dPNE | Experimental | Each patient receive a single intravenous injection of 68GA-DOTA-dPNE 0.05-0.06 mci/kg and undergo PET/CT Receives: Drug: 68GA-DOTA-dPNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer
Patients with histologically proven breast cancer will be prospectively recruited in this study. They will receive 68Ga-DOTA-dPNE and 18F-FDG. The detection rates of lesions, bones and lymph nodes (visual) were compared.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianzhong ZHANG, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411678
- Sponsor's protocol ID
- PUMCH-NM-CD73
- Status last verified
- Aug 2026
- First submitted
- 8 May 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
- ClinicalTrials.gov ID
- NCT06411678
- Acronym / sponsor ID
- PUMCH-NM-CD73
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2024 (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.
The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. As part of the study design, a subset of patients will initially undergo dynamic PET/CT imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. Subsequently, static PET/CT imaging will be performed on additional patients to assess the diagnostic effectiveness of 68Ga-DOTA-dPNE. Imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68GA-DOTA-dPNE | Experimental | Drug: 68GA-DOTA-dPNEEach patient receive a single intravenous injection of 68GA-DOTA-dPNE 0.05-0.06 mci/kg and undergo PET/CT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged ≥18 years with an expected survival of at least 12 weeks No prior radiotherapy or chemotherapy; surgery or biopsy is feasible for pathological diagnosis At least one measurable target lesion as defined by RECIST v1.1 Able to provide written informed consent and comply with follow-up requirements
Key exclusion criteria (1 listed)
- Severe hepatic or renal dysfunction Pregnant, breastfeeding, planning to become pregnant, or planning to have children during the study period; women of childbearing potential must use effective contraception during the study Unable to lie flat for 30 minutes History of claustrophobia or other psychiatric disorders Any other condition deemed unsuitable for participation by the investigator Refusal to participate in the clinical 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-DOTA-dPNEPatients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after 40min of injection | Drug | 68GA-DOTA-dPNE |
Primary outcome
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer
Time frame: through study completion, an average of 1 year
Patients with histologically proven breast cancer will be prospectively recruited in this study. They will receive 68Ga-DOTA-dPNE and 18F-FDG. The detection rates of lesions, bones and lymph nodes (visual) were compared.
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 21 Sep 2026.
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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.
Xianzhong ZHANG 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-DOTA-dPNE in people with Breast Cancer, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
Contact Chenhao JIA (18548703382, jiachenhao24@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer (time frame: through study completion, an average of 1 year). 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 21 Sep 2026.