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Trial Title:
A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular Carcinoma
NCT ID:
NCT06148155
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Positron-Emission Tomography
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
[68Ga]Ga-NOTA-RG2 PET Imaging
Description:
Intravenous injection of 1.8 MBq [0.05MCi]/kg of [68Ga]Ga-NOTA-RG2 in a single dose.
Arm group label:
patients with primary and/or metastatic hepatocellular carcinoma (HCC)
Summary:
The aim of this study was to establish and optimize the imaging method of
[68Ga]Ga-NOTA-RG2, as well as its physiological and pathological distribution
characteristics, and on this basis to evaluate the diagnostic efficacy of the above
imaging agents in patients with hepatocellular carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Hepatocellular carcinoma patients
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:
- Subjects meeting any of the following criteria will be excluded from the study:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Yihui Guan
Phone:
+8613764308300
Email:
guanyihui@hotmail.com
Start date:
June 1, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06148155
