Malignant TumourEarly Phase 1NCT06995976
Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73
A Early Phase 1 study testing 68Ga-dPNE and 18F-FDG in people with Malignant Tumour, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumour
- What is being tested?
- 68Ga-dPNE and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent and be able to follow up.
Who cannot join
- Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Furthermover, we conducted a comparative analysis of 68Ga-dPNE and 18F-FDG imaging to assess both the radiation dosimetry and diagnostic efficacy of 68Ga-dPNE.
Read the detailed description
The boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. CD73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. Notably, CD73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-dPNE, and performed a head-to-head comparison with 18F-FDG PET/CT scans in patients with various cancers.
- Conditions
- Malignant Tumour
- Being tested
- 68Ga-dPNE, 18F-FDG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-dPNEDrug
Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors.
18F-FDGDrug
Intravenous injection of 18F-FDG.18F-FDG PET/CT will be used to detect tumors.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-dPNE PET/CT | Experimental | Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors. Receives: Drug: 68Ga-dPNE |
| 18F-FDG PET/CT | Experimental | Intravenous injection of 18F-FDG. 18F-FDG PET/CT will be used to detect tumors. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV of tumors
Compare the SUV of tumors between 68Ga-dPNE PET/CT and 18F-FDG PET/CT.
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
Diagnostic value
Sensitivity and specificity of 68Ga-dPNE in patients with various types of cancer and compare it with 18F-FDG PET/CT.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumourStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995976
- Sponsor's protocol ID
- FirstAHFujian-CD73
- Status last verified
- Oct 2026
- First submitted
- 21 May 2025
- Last updated
- 21 Oct 2026
- Results posted
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73
- ClinicalTrials.gov ID
- NCT06995976
- Acronym / sponsor ID
- FirstAHFujian-CD73
- Conditions
- Malignant Tumour
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 30 May 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.
As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Furthermover, we conducted a comparative analysis of 68Ga-dPNE and 18F-FDG imaging to assess both the radiation dosimetry and diagnostic efficacy of 68Ga-dPNE.
Detailed description
The boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. CD73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. Notably, CD73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-dPNE, and performed a head-to-head comparison with 18F-FDG PET/CT scans in patients with various cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-dPNE PET/CT | Experimental | Drug: 68Ga-dPNEIntravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors. |
| 18F-FDG PET/CT | Experimental | Drug: 18F-FDGIntravenous injection of 18F-FDG. 18F-FDG PET/CT will be used to detect tumors. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent and be able to follow up.
Key exclusion criteria (1 listed)
- Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
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-dPNEIntravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors. | Drug | 68Ga-dPNE PET/CT |
| 18F-FDGIntravenous injection of 18F-FDG.18F-FDG PET/CT will be used to detect tumors. | Drug | 18F-FDG PET/CT |
Primary outcome
SUV of tumors
Time frame: Through study completion, an average of 3 months
Compare the SUV of tumors between 68Ga-dPNE PET/CT and 18F-FDG PET/CT.
1 secondary outcome
Diagnostic value
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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. This study is not recruiting at the moment.
Weibing Miao, MD principal investigator
First Affiliated Hospital of Fujian Medical University
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-dPNE and 18F-FDG in people with Malignant Tumour, run by First Affiliated Hospital of Fujian Medical University 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: finished, as of the sponsor's last update on 21 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of tumors (time frame: Through study completion, an average of 3 months). 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 Oct 2026.