Clinical Trials List
Protocol NumberNARI-V09DX-proton-k
Active
2025-03-01 - 2026-12-31
Others
Recruiting1
ICD-10C22.0
Liver cell carcinoma
ICD-10C22.2
Hepatoblastoma
ICD-10C22.3
Angiosarcoma of liver
ICD-10C22.4
Other sarcomas of liver
ICD-10C22.7
Other specified carcinomas of liver
ICD-10C22.8
Malignant neoplasm of liver, primary, unspecified as to type
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9155.0
Malignant neoplasm of liver, primary
A prospective study using gallium-68-Dorec gallium dynamic positron emission tomography to assess residual liver function in liver cancer patients before and after proton therapy.
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Sponsor
Nuclear Medicine and Pharmaceutical Center, National Institute of Atomic Energy
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Trial scale
Taiwan Single Center
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Update
2026/08/12
Investigators and Locations
Principal Investigator
黃炳勝
Co-Principal Investigator
- Kung-Chu Ho Division of Nuclear Medicine
- 李靜欣 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Diagnostic drugs for liver function
Objectives
Primary objective: To compare residual liver function in liver cancer patients before and after proton therapy using gallium-68-dolex gallium.
Secondary objective: To evaluate the safety of gallium-68-dolex gallium in liver cancer patients.
Test Drug
Nuclear research on Dorex gallium liver function contrast agent
Active Ingredient
NOTA-Hexa lactoside (INER038)
Dosage Form
N/A
Dosage
40mcg/2mL
Endpoints
1. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of liver stock before proton therapy (expressed as percentage of injection dose %ID and standard uptake value SUV).
2. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of liver stock after proton therapy (expressed as percentage of injection dose %ID and standard uptake value SUV).
3. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of tumor size before proton therapy, where the tumor uptake rate is less than 60% of that in other liver areas (expressed in cubic centimeters cm³).
4. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of tumor size after proton therapy, where the tumor uptake rate is less than 60% of that in other liver areas (expressed in cubic centimeters cm³).
2. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of liver stock after proton therapy (expressed as percentage of injection dose %ID and standard uptake value SUV).
3. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of tumor size before proton therapy, where the tumor uptake rate is less than 60% of that in other liver areas (expressed in cubic centimeters cm³).
4. Gallium 68-Dorec gallium positron emission tomography (Ga6P) assessment of tumor size after proton therapy, where the tumor uptake rate is less than 60% of that in other liver areas (expressed in cubic centimeters cm³).
Inclution Criteria
(1) Diagnosed with liver cancer and scheduled for proton therapy.
(2) Men and women aged 20 and over and under 80 years of age – women of childbearing age (i.e., premenopausal women who have not undergone surgical sterilization), or male subjects whose partners are women of childbearing age, must be willing to use highly effective contraception during the trial. Highly effective contraception includes: hormonal contraception (oral, injectable, or implantable), intrauterine devices (IUDs), bilateral tubal obstruction, partner sterilization, or abstinence.
(3) Performance status: ECOG 0-1
(4) Liver function: Child-Pugh class A
(2) Men and women aged 20 and over and under 80 years of age – women of childbearing age (i.e., premenopausal women who have not undergone surgical sterilization), or male subjects whose partners are women of childbearing age, must be willing to use highly effective contraception during the trial. Highly effective contraception includes: hormonal contraception (oral, injectable, or implantable), intrauterine devices (IUDs), bilateral tubal obstruction, partner sterilization, or abstinence.
(3) Performance status: ECOG 0-1
(4) Liver function: Child-Pugh class A
Exclusion Criteria
(1) Massive or uncontrollable ascites
(2) Concomitant malignant tumors
(3) Pregnant or lactating women or a positive pregnancy test
(4) Distant metastasis of the tumor
(5) Hypersensitivity to the investigational drug or similar drugs
(6) Hypersensitivity to Primovist contrast agent
(7) Acute or chronic severe kidney disease (glomerular filtration rate <30 mL/min/1.73m2)
(8) Common exclusion criteria for PET and MRI examinations
(9) Subjects who cannot be followed up for any reason
(2) Concomitant malignant tumors
(3) Pregnant or lactating women or a positive pregnancy test
(4) Distant metastasis of the tumor
(5) Hypersensitivity to the investigational drug or similar drugs
(6) Hypersensitivity to Primovist contrast agent
(7) Acute or chronic severe kidney disease (glomerular filtration rate <30 mL/min/1.73m2)
(8) Common exclusion criteria for PET and MRI examinations
(9) Subjects who cannot be followed up for any reason
The Estimated Number of Participants
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Taiwan
15 participants
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Global
15 participants
