Clinical trial NCT06383520: Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
Official title: Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm of Liver
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens.

Detailed description: Liver cancer is one of the most common malignant tumors in the world, and hepatocellular carcinoma (HCC) is the most prominent histopathological type. Surgical resection and liver transplantation are the main radical methods for early HCC patients. However, due to its insidious onset, more than 90% of HCC patients are already in local advanced stage or accompanied by distant metastasis when diagnosed, so there is no surgical opportunity and the prognosis is very poor. It is important to explore new methods and strategies for early and accurate diagnosis of HCC to improve the prognosis of patients.

Traditional imaging methods such as multi-temporal computed tomography (CT) and magnetic resonance imaging (MRI) have been widely used in the diagnosis, staging and treatment decision making of HCC, but qualitative diagnosis cannot be achieved. Nuclear medicine diagnostic tool \[18F\]-Fluorodeoxyglucose positron emission tomography/computed tomography (\[18F\]-FDG PET/CT) imaging technology has been widely used in the diagnosis of a variety of malignant tumors, but due to its low diagnostic accuracy for HCC, especially highly differentiated HCC, its value in the early diagnosis of HCC is limited.

GPC3, a member of the heparan sulfate glycoprotein family, is composed of a core protein, two heparan sulfate chains located at the C-terminal and phosphatidyl inositol anchors attached to the cell membrane. Data analysis showed that GPC3 was significantly overexpressed in tumor cells of HCC patients, but hardly expressed in normal liver tissue or in benign liver diseases, making it the most specific tumor marker for HCC. High expression of GPC3 is associated with poor prognosis in HCC. patients,.suggesting that GPC3 may be an important molecular target for accurate diagnosis and treatment of HCC.

This project proposes to PET imaging targeting GPC3 in the diagnosis and staging of HCC and to compare the diagnostic efficacy with the pathology gold standard. And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing PET imaging targeting GPC3 with the commonly used 18F-FDG PET imaging.

Eligibility criteria: Inclusion Criteria:

* 1: Voluntarily participate and the person or their legal representative can sign an informed consent form
* 2: Adult patients (18 years of age or older), regardless of gender
* 3: Patients with newly diagnosed hepatocellular carcinoma with high clinical suspicion or confirmation (supporting evidence including imaging data and histopathologic examination, etc.) who agree to undergo histopathologic examination (if not performed prior to imaging) or/and 18F-FDG PET imaging
* 4: Healthy volunteer
* 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment
* 6: Willing and able to follow schedule visits, treatment plans and laboratory tests

Exclusion Criteria:

* 1: Pregnant or lactating patients
* 2: The patient or their legal representative is unable or unwilling to sign the informed consent form
* 3: Acute systemic diseases and electrolyte disorders
* 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients
* 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG
* 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)
* 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment

Primary outcomes:
measure: Visual and standardized uptake values assessment of lesions and biodistribution
timeFrame: 1 year
Secondary outcomes:
measure: Radioactivity in the blood and urine samples
timeFrame: 1 year
measure: Concentration of tumor markers (e.g., APF) in participants' blood
timeFrame: 1 year
measure: Pathological sections of tumour tissue
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: China, Hubei Province
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: STUDY_DIRECTOR
References: