To hear about similar clinical trials, please enter your email below
Trial Title:
The AMARA (As Much As Reasonably Achievable) Study
NCT ID:
NCT06257030
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Transarterial Radioembolization
Description:
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure
performed by the interventional radiologist for the treatment of primary and secondary
hepatic cancers.
Arm group label:
TARE group
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. 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.
Criteria for eligibility:
Study pop:
Individuals presenting with either primary or metastatic hepatic malignancies are the
study population.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- Child Pugh > B
- Bilirubin >2 mg/dl
- Albumin<3.0
- Central portal invasion
- Multi-focal bilobar disease
- Disseminated extrahepatic disease
- Lung shunt >20% or a estimated Lung dose > 20 Gy
- Focuses of extra-hepatic liver uptake.
- Patients that cannot tolerate addition follow-up imaging.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Patras
Address:
City:
Patra
Zip:
26500
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Theoni Kaplanidou
Phone:
006973424965
Email:
theoni.kaplanidou@gmail.com
Start date:
February 5, 2024
Completion date:
February 5, 2027
Lead sponsor:
Agency:
University Hospital of Patras
Agency class:
Other
Source:
University Hospital of Patras
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06257030
