Epithelial Tumors, MalignantNCT07400263
Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors
A study testing [68Ga]Ga-PN-EpC1 PET/CT in people with Epithelial Tumors, Malignant, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this prospective, single-arm clinical trial is to evaluate the imaging performance and safety of an EpCAM-targeted radiotracer, [68Ga]Ga-PN-EpC1, in patients with epithelial tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Tumors, Malignant
- What is being tested?
- [68Ga]Ga-PN-EpC1 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosed or suspected tumors visiting the hospital between January 2026 and December 2026, who are scheduled for pathological biopsy or surgical treatment within 2 months.
- Age > 18 years, regardless of gender.
- Adequate organ and bone marrow function as defined by the following laboratory values:
- Hematology: WBC ≥4.0×10^9/L or ANC ≥1.5×10^9/L; PLT ≥100×10^9/L; Hemoglobin ≥90 g/L.
- Liver Function: Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN (or ≤5× ULN if liver metastases are present).
- Renal Function: BUN ≤1.5× ULN; Serum Creatinine (SCr) ≤1.5× ULN.
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- Normal cardiac function.
- Expected life expectancy ≥12 weeks.
- Presence of at least one measurable target lesion according to RECIST v1.1 criteria.
- Patients recommended by clinicians to undergo PET/CT examination for tumor diagnosis and staging.
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of reproductive age must agree to use effective contraception during the study and for at least 3 months after the examination.
- Voluntarily participate in the study, demonstrate full understanding of the protocol, and provide written informed consent.
Who cannot join
- Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
- History of allergic diseases.
- Patients planning for pregnancy during the study period.
- Pregnant or lactating women.
- Inability to maintain a supine position for at least 30 minutes.
- Patients with claustrophobia or other diagnosed psychiatric disorders that may interfere with compliance.
- Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the evaluation of the study results.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xing Yang, 00-86-010-88316643, yangxing2017@bjmu.edu.cn
About this study
Official title: A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
The goal of this prospective, single-arm clinical trial is to evaluate the imaging performance and safety of an EpCAM-targeted radiotracer, [68Ga]Ga-PN-EpC1, in patients with epithelial tumors.
The main questions it aims to answer are:
- What is the sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting EpCAM-positive tumor lesions?
- How does the radiotracer uptake correlate with EpCAM expression assessed by immunohistochemistry?
- Is [68Ga]Ga-PN-EpC1 safe and well tolerated when administered for PET/CT imaging in patients with epithelial tumors? Participants will undergo [68Ga]Ga-PN-EpC1 PET/CT imaging prior to tumor biopsy or surgical resection. Imaging findings will be analyzed and compared with histopathological results and standard imaging assessments. Safety will be evaluated by monitoring adverse events following radiotracer administration.
- Conditions
- Epithelial Tumors, Malignant
- Being tested
- [68Ga]Ga-PN-EpC1 PET/CT
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PN-EpC1 PET/CTDiagnostic test
Participants will receive a single intravenous administration of the EpCAM-targeted radiotracer [68Ga]Ga-PN-EpC1 for PET/CT imaging. The radiotracer will be administered at a dose of 0.05-0.1 mCi/kg, followed by whole-body PET/CT acquisition according to the study imaging protocol. Additional dynamic or delayed imaging may be performed in selected participants.
| Study group | Role | What they receive |
|---|---|---|
| EpCAM PET | Experimental | Not described Receives: Diagnostic Test: [68Ga]Ga-PN-EpC1 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting epithelial tumor lesions, using histopathological results as the reference standard.
Measured: From PET/CT imaging to histopathological confirmation within 2 months.
Secondary outcomes (3)
Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection
The specificity and overall diagnostic accuracy of [68Ga]Ga-PN-EpC1 PET/CT in identifying epithelial tumor lesions, using histopathological results as the reference standard.
Measured: From PET/CT imaging to histopathological confirmation within 2 months.
Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels
To evaluate the correlation between the intensity of tracer uptake (e.g., SUVmax, SUVmean) on PET/CT images and the expression level of EpCAM in tumor tissues as determined by immunohistochemistry (IHC).
Measured: From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).
Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging
Assessment of the incidence and severity of adverse events (AEs) related to the administration of [68Ga]Ga-PN-EpC1, monitored via vital signs and patient reporting.
Measured: Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start4 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Tumors, MalignantStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Yang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400263
- Sponsor's protocol ID
- 2025PHB625
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
- ClinicalTrials.gov ID
- NCT07400263
- Acronym / sponsor ID
- 2025PHB625
- Conditions
- Epithelial Tumors, Malignant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (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 goal of this prospective, single-arm clinical trial is to evaluate the imaging performance and safety of an EpCAM-targeted radiotracer, [68Ga]Ga-PN-EpC1, in patients with epithelial tumors.
The main questions it aims to answer are:
- What is the sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting EpCAM-positive tumor lesions?
- How does the radiotracer uptake correlate with EpCAM expression assessed by immunohistochemistry?
- Is [68Ga]Ga-PN-EpC1 safe and well tolerated when administered for PET/CT imaging in patients with epithelial tumors? Participants will undergo [68Ga]Ga-PN-EpC1 PET/CT imaging prior to tumor biopsy or surgical resection. Imaging findings will be analyzed and compared with histopathological results and standard imaging assessments. Safety will be evaluated by monitoring adverse events following radiotracer administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EpCAM PET | Experimental | Diagnostic Test: [68Ga]Ga-PN-EpC1 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with diagnosed or suspected tumors visiting the hospital between January 2026 and December 2026, who are scheduled for pathological biopsy or surgical treatment within 2 months.
- Age > 18 years, regardless of gender.
- Adequate organ and bone marrow function as defined by the following laboratory values:
- Normal cardiac function.
- Expected life expectancy ≥12 weeks.
Key exclusion criteria (7 listed)
- Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
- History of allergic diseases.
- Patients planning for pregnancy during the study period.
- Pregnant or lactating women.
- Inability to maintain a supine position for at least 30 minutes.
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]Ga-PN-EpC1 PET/CTParticipants will receive a single intravenous administration of the EpCAM-targeted radiotracer [68Ga]Ga-PN-EpC1 for PET/CT imaging. The radiotracer will be administered at a dose of 0.05-0.1 mCi/kg, followed by whole-body PET/CT acquisition according to the study imaging protocol. Additional dynamic or delayed imaging may be performed in selected participants. | Diagnostic test | EpCAM PET |
Primary outcome
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection
Time frame: From PET/CT imaging to histopathological confirmation within 2 months.
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for detecting epithelial tumor lesions, using histopathological results as the reference standard.
3 secondary outcomes
Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection
Time frame: From PET/CT imaging to histopathological confirmation within 2 months.
Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels
Time frame: From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).
Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging
Time frame: Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.
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 30 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PN-EpC1 PET/CT in people with Epithelial Tumors, Malignant, run by Peking University People's 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 12 inclusion and 7 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 30 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection (time frame: From PET/CT imaging to histopathological confirmation within 2 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 30 Mar 2026.