Hepatocellular Carcinoma (HCC)
Conditions
Keywords
68Ga-NYM207, GPC3
Brief 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). 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.
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.
Interventions
DIAGNOSTIC_TEST68Ga-NYM207 PET/CT
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age and of either gender; 2. Written informed consent provided for participation in the trial; 3. At least one of the following indications should be applied: 1. scheduled for surgical resection or biopsy of the liver mass within one month; 2. with a history of HCC, recurrence or metastasis during follow-up (based on histopathologic examination or typical appearance of imaging data including conventional imaging or 18F-FDG PET/CT scan); 4. Willing and able to follow schedule visits, treatment plans and laboratory tests.
Exclusion criteria
1. Pregnancy or lactation; 2. Severe claustrophobia; 3. On treatment with anti-tumor drugs targeting GPC3; 4. Any condition deemed by the investigator to interfere with study results or increase participant risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A) | From study completion to 1 month after completion | Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded. |
| Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B) | From study completion to 1 month after completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry of 68Ga-NYM207 | From study completion to 1 month after completion | OLINDA/EXM will be used to determine the absorbed dose and effective dose per patient. |
| SUVmax of focal lesions identified on 68Ga-NYM207 PET/CT | From study completion to 1 month after completion | 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. |
| Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT | From study completion to 1 month after completion | Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. |
| Intensity of GPC3 staining of lesions with pathological results | From study completion to 1 month after completion | The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003 |
Countries
China
Contacts
CONTACTLi Huo
CONTACTWenjia Zhu
Outcome results
None listed