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The AMARA (As Much As Reasonably Achievable) Study

ConditionLiver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 yr

Both sexes eligible for study

Patients with primary or secondary liver tumors

Liver dominant disease

Disqualifiers

Child Pugh > B

Bilirubin >2 mg/dl

Albumin<3.0

Central portal invasion

Trial population

Individuals presenting with either primary or metastatic hepatic malignancies are the study population.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transarterial Radioembolization

    Device

    (TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: TARE group1 intervention

Trial outcomes

Primary outcomes

1

Complications

Adverse Events related with the procedure

Time frame
6 months
2

LPFS

Liver Progression Free Survival after the procedure

Time frame
2 years
3

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.

Time frame
2 years

Secondary outcomes

1

Post-treatment dosimetry analysis

Correlate the safety and efficacy with the post-treatment dosimetry analysis

Time frame
2 years

Other outcomes

Sponsors and contacts

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University Hospital of Patras

Lead sponsor

Source ClinicalTrials.gov
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