Liver CancerNCT06257030
The AMARA (As Much As Reasonably Achievable) Study
An observational study of Liver Cancer, run by University Hospital of Patras at 1 site in Greece.
Trial summary
Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose >200Gy by the partition model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Transarterial Radioembolization
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 5 Feb 2024to 5 Feb 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting with either primary or metastatic hepatic malignancies are the study population.
Who may be able to join
- Age >18 yr
- Both sexes eligible for study
- Patients with primary or secondary liver tumors
- Liver dominant disease
- At least one lesion greater than 5.0 cm in maximum diameter
- Life-expectancy > 3 months
Show all 10Show fewer
- FLR >40% or greater than 500mls
- Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
- Able to schedule and tolerate post-treatment Y90 PET/CT imaging
- Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.
Who cannot join
- Child Pugh > B
- Bilirubin >2 mg/dl
- Albumin<3.0
- Central portal invasion
- Multi-focal bilobar disease
- Disseminated extrahepatic disease
Show all 9Show fewer
- Lung shunt >20% or a estimated Lung dose > 20 Gy
- Focuses of extra-hepatic liver uptake.
- Patients that cannot tolerate addition follow-up imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras
Pátrai, Achaia, 26500
Theoni Kaplanidou, 006973424965, theoni.kaplanidou@gmail.com
About this study
Official title: The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose >200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.
- Conditions
- Liver Cancer
- Being tested
- Transarterial Radioembolization
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial RadioembolizationDevice
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
| Study group | Role | What they receive |
|---|---|---|
| TARE group | (TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers. Receives: Device: Transarterial Radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Adverse Events related with the procedure
Measured: 6 months
LPFS
Liver Progression Free Survival after the procedure
Measured: 2 years
Tumor Response
Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated.
Measured: 2 years
Secondary outcomes (1)
Post-treatment dosimetry analysis
Correlate the safety and efficacy with the post-treatment dosimetry analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start5 Feb 2024
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Konstantinos Katsanos, University Hospital of Patras
- Investigators
- Platon Dimopoulos, Resident, Study director, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257030
- Sponsor's protocol ID
- 735
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
- ClinicalTrials.gov ID
- NCT06257030
- Acronym / sponsor ID
- 735
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 13 Feb 2024 (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.
Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose >200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TARE group | – | Device: Transarterial Radioembolization(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting with either primary or metastatic hepatic malignancies are the study population.
Key inclusion criteria (10 listed)
- Age >18 yr
- Both sexes eligible for study
- Patients with primary or secondary liver tumors
- Liver dominant disease
- At least one lesion greater than 5.0 cm in maximum diameter
Key exclusion criteria (9 listed)
- Child Pugh > B
- Bilirubin >2 mg/dl
- Albumin<3.0
- Central portal invasion
- Multi-focal bilobar disease
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 |
|---|---|---|
| Transarterial Radioembolization(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers. | Device | TARE group |
Primary outcome
Complications
Time frame: 6 months
Adverse Events related with the procedure
LPFS
Time frame: 2 years
Liver Progression Free Survival after the procedure
Tumor Response
Time frame: 2 years
Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated.
1 secondary outcome
Post-treatment dosimetry analysis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Platon Dimopoulos, Resident study director
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by University Hospital of Patras at 1 site in Greece.
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 10 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: looking for participants now, as of the sponsor's last update on 24 Apr 2024. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Katsanos, Professor (+306978225019, katsanos@med.upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 6 months). The study lists 3 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 24 Apr 2024.