Hepatic Carcinoma
Conditions
Brief summary
This is a single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy.
Detailed description
This is a single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy. This trial will enroll 10 eligible subjects. All subjects will provide informed consent before any study procedures are performed. Screening procedures (visit 1) will occur within 21 days prior to imaging visit (visit 2) and will include: inclusion/exclusion criteria check, pregnancy test (if applicable), vital signs, laboratory tests, electrocardiogram (ECG) and establishment of baseline characteristics. Primovist MRI will occur within 14 days prior to imaging visit (visit 2) and 1 week after imaging visit (visit 4), and will be performed according to standard procedure of study site. The baseline characteristics include medical/medication history, fibrosis index, Child-Pugh score and classification, MELD score, liver oncology diagnosis, tumor size, preoperative treatments (portal vein embolization, transarterial chemoembolization, transarterial embolization or biliary drainage), existence of thrombosis (portal vein thrombosis or hepatic vein thrombosis). The liver tissue fibrosis index FIB-4 will be measured to assess the morphological changes. During the imaging session (visit 2, Day 1; visit 4, Day 84±3), a catheter will be placed for intravenous (IV) administration of Ga-68 Dolacga. Subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga-68 Dolacga. A PET/CT scan will be kinetically performed for 60 minutes immediately after IV injection. The measurement of liver reserve is the primary endpoints of this study and measurement will be evaluated by Ga-68 Dolacga PET. The measurement of liver reserve will be performed at visit 2 and visit 4 of this study for all subjects. Adverse events will be continuously monitored during the imaging session. Two follow-up visits (visit 3 at Day 7±2 and visit 5 at Day 91±2) will be conducted to confirm subject well-being and to collect information about any new adverse events (if any).
Interventions
DRUGGa-68 Dolacga Injection
Ga-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
Sponsors
National Atomic Research Institute, Taiwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with hepatocellular carcinoma and scheduled to have the PBT. * 20\ 80 years old * Performance status: ECOG 0-1 * Child-Pugh class A
Exclusion criteria
* Massive or uncontrolled ascites * Concurrent with other malignancy * Under pregnancy or breastfeeding * With distant metastasis * Allergic to investigational drug(s) or similar drug(s)/ formulation(s); * Known hypersensitivity to PRIMOVIST * Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m\^2) * General PET and MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy. | Visit 2 (Day 1) | The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in percentage of injection dose (%ID) and standard uptake value, (SUV). |
| Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients after proton therapy. | Visit 4 (Day 84±3) | The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in percentage of injection dose (%ID) and standard uptake value, (SUV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically significant changes in Heart Rate | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Number of subjects reporting clinically significant changes in serum biochemical tests | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Number of subjects reporting clinically significant changes in hematological tests | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Number of subjects with clinically significant changes in electrocardiogram(ECG) | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 91 days | All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved. |
| Number of subjects reporting clinically significant changes in urinalysis | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
| Number of subjects with body temperature abnormalities | from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2) | — |
Countries
Taiwan
Contacts
Primary ContactMei-Hui Wang, PhD
Outcome results
None listed