A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular Carcinoma
NCT ID: NCT06148155
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-06-01
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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patients with primary and/or metastatic hepatocellular carcinoma (HCC)
The diagnosis of HCC is established by surgery or biopsy pathology.
[68Ga]Ga-NOTA-RG2 PET Imaging
Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[68Ga\]Ga-NOTA-RG2 in a single dose.
Interventions
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[68Ga]Ga-NOTA-RG2 PET Imaging
Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[68Ga\]Ga-NOTA-RG2 in a single dose.
Eligibility Criteria
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Inclusion Criteria
1. Age between 18 and 65 years old, gender is not limited.
2. Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP\>200 ug/L who have not undergone surgery.
3. Patients with hepatocellular carcinoma confirmed by puncture pathology
4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
5. Willingness and ability to cooperate with all programs of the study.
Exclusion Criteria
1. Patients receiving anti-tumor therapy prior to the PET/CT scan.
2. Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
3. Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
4. Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
5. Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
6. The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.
18 Years
65 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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YiHui Guan
Professor
Principal Investigators
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Fang Xie, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2023-544
Identifier Type: -
Identifier Source: org_study_id
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