The AMARA (As Much As Reasonably Achievable) Study
NCT06257030 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2024-04-24
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
University Hospital of Patras
lead OTHER
Principal Investigators
-
Platon Dimopoulos, Resident · University Hospital of Patras
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-05
- Primary Completion
- 2027-02-05
- Completion
- 2027-02-05
- FDA Device
- Yes
Countries
- Greece
Study Locations
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