Hepatic CarcinomaNCT06182865
A Study of Ga-68 Dolacga to Evaluate Liver Reserve Function in Patients With HCC Before and After Proton Therapy
A study testing Ga-68 Dolacga Injection in people with Hepatic Carcinoma, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- Ga-68 Dolacga Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hepatocellular carcinoma and scheduled to have the PBT.
- 20~80 years old
- Performance status: ECOG 0-1
- Child-Pugh class A
Who cannot join
- 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
Show all 9Show fewer
- Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m^2)
- General PET and MRI exclusion criteria
- Can't follow our follow-up schedule because of any reason
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Linkon Chang Gung Memorial Hospital
Taoyuan City, 333423
Bing-Shen Huang, MD, +886-3-3281200 ext. 7000, beanson.tw@gmail.com
About this study
Official title: A Prospective Study of Ga-68 Dolacga Scintigraphy to Evaluate Liver Reserve Function in Patients With Hepatocellular Carcinoma Before and After Proton Therapy
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.
Read the 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).
- Conditions
- Hepatic Carcinoma
- Being tested
- Ga-68 Dolacga Injection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 Dolacga InjectionDrug
Ga-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Ga-68 Dolacga Injection | Experimental | Ga-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus Receives: Drug: Ga-68 Dolacga Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.
The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."
Measured: Visit 2 (Day 1)
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients after proton therapy.
The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."
Measured: Visit 4 (Day 84±3)
Secondary outcomes (8)
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Measured: 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
Measured: 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 Heart Rate
Measured: 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
Measured: 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
Measured: 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 urinalysis
Measured: 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)
Measured: 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)
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.
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Atomic Research Institute, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing-Shen Huang, MD, Principal investigator, Linkon Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182865
- Sponsor's protocol ID
- INER-V09DX-proton
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Ga-68 Dolacga Scintigraphy to Evaluate Liver Reserve Function in Patients With Hepatocellular Carcinoma Before and After Proton Therapy
- ClinicalTrials.gov ID
- NCT06182865
- Acronym / sponsor ID
- INER-V09DX-proton
- Conditions
- Hepatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Atomic Research Institute, TaiwanUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga-68 Dolacga Injection | Experimental | Drug: Ga-68 Dolacga InjectionGa-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with hepatocellular carcinoma and scheduled to have the PBT.
- 20~80 years old
- Performance status: ECOG 0-1
- Child-Pugh class A
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 Dolacga InjectionGa-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation. | Drug | Ga-68 Dolacga Injection |
Primary outcome
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.
Time frame: 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.
Time frame: 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)."
8 secondary outcomes
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Time frame: 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
Time frame: 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 Heart Rate
Time frame: 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
Time frame: 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
Time frame: 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 urinalysis
Time frame: 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)
Time frame: 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)
Time frame: 91 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing-Shen Huang, MD principal investigator
Linkon Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68 Dolacga Injection in people with Hepatic Carcinoma, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Hui Wang, PhD (+886-3-4711400 ext. 7162, mhwang@nari.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy. (time frame: Visit 2 (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.