The AMARA (As Much As Reasonably Achievable) Study

Liver Cancer Clinical Trial

Official title:

The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257030
• Other study ID #: 735
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: February 5, 2027

Study information

• Verified date: April 2024
• Source: University Hospital of Patras
• Contact: Konstantinos Katsanos, Professor
• Phone: +306978225019
• Email: katsanos[@]med.upatras.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 5, 2027
• Est. primary completion date: February 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patra	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Adverse Events related with the procedure	6 months
Primary	LPFS	Liver Progression Free Survival after the procedure	2 years
Primary	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.	2 years
Secondary	Post-treatment dosimetry analysis	Correlate the safety and efficacy with the post-treatment dosimetry analysis	2 years