Hepatocellular Carcinoma (HCC)Phase 1/2NYHCCNCT07590336
68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma
A Phase 1/2 study testing 68Ga-NYM207 PET/CT in people with Hepatocellular Carcinoma (HCC), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm, phase I/II study designed to evaluate (1) the safety, tolerability, and imaging characteristics of 68Ga-NYM207 (Phase A), and (2) the diagnostic performance of 68Ga-NYM207 in detecting hepatocellular carcinoma (HCC) (Phase B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- 68Ga-NYM207 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to 1 Apr 2027
- Phase
- Phase 1/2
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
- ≥18 years of age and of either gender;
- Written informed consent provided for participation in the trial;
- At least one of the following indications should be applied:
- scheduled for surgical resection or biopsy of the liver mass suspected of HCC within one month;
- with a history of HCC, recurrence or metastasis during follow-up (based on laboratory examination or typical appearance of imaging data including conventional imaging or 18F-FDG PET/CT scan);
- Willing and able to follow schedule visits, treatment plans and laboratory tests.
Who cannot join
- Pregnancy or lactation;
- Severe claustrophobia;
- On treatment with anti-tumor drugs targeting GPC3;
- Any condition deemed by the investigator to interfere with study results or increase participant risk.
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 Union Medical College Hospital
Beijing, 100730
Wenjia Zhu, +86 18614080164, zhuwenjia_pumc@163.com
About this study
Official title: Study on the Clinical Application of GPC3-targeting 68Ga-NYM207 PET/CT in Hepatocellular Carcinoma
This is a prospective, single-center, single-arm, phase I/II study designed to evaluate (1) the safety, tolerability, and imaging characteristics of 68Ga-NYM207 (Phase A), and (2) the diagnostic performance of 68Ga-NYM207 in detecting hepatocellular carcinoma (HCC) (Phase B). This study will provide critical insights into the performance of 68Ga-NYM207 PET/CT as a non-invasive imaging tool for the detection of HCC.
Read the detailed description
Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Safety, tolerability and imaging characteristics of ⁶⁸Ga-NYM207 will be evaluated. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68Ga-NYM207 PET/CT.
Patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- 68Ga-NYM207 PET/CT
- Keywords
- 68Ga-NYM207, GPC3
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NYM207 PET/CTDiagnostic test
Participants will be administered a single, intravenous bolus of 68Ga-NYM207. The recommended administered activity of 68Ga-NYM207 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ge/68Ga generator. For biodistribution and imaging characteristics evaluation, PET scans will be performed at 15min, 30min, 60min, and 120min after 68Ga-NYM207 administration. For diagnostic performance study, the CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM207 administration.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NYM207 PET/CT | Experimental | 68Ga-NYM207 PET/CT Each patient will receive one dose of 68Ga-NYM207 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Receives: Diagnostic Test: 68Ga-NYM207 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A)
Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded.
Measured: From study completion to 1 month after completion
Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B)
Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of68Ga-NYM207 will be interpreted as PET positive.
Measured: From study completion to 1 month after completion
Secondary outcomes (4)
Dosimetry of 68Ga-NYM207
OLINDA/EXM will be used to determine the absorbed dose and effective dose per patient.
Measured: From study completion to 1 month after completion
SUVmax of focal lesions identified on 68Ga-NYM207 PET/CT
Tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.
Measured: From study completion to 1 month after completion
Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT
Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue.
Measured: From study completion to 1 month after completion
Intensity of GPC3 staining of lesions with pathological results
The intensity of GPC3 staining of operated liver lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003
Measured: From study completion to 1 month after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start11 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590336
- Sponsor's protocol ID
- K10590
- Acronym
- NYHCC
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request