The AMARA (As Much As Reasonably Achievable) Study

NCT06257030 | Recruiting DMC FDA Device

• 1 other identifier: 735
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cancer

Outcome Measures

Primary Outcomes (3)

• Complications

  Adverse Events related with the procedure

  6 months

• LPFS

  Liver Progression Free Survival after the procedure

  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.

  2 years

Secondary Outcomes (1)

• Post-treatment dosimetry analysis

  2 years

Study Arms (1)

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.

Device: Transarterial Radioembolization

Interventions

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.

TARE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Platon Dimopoulos, Resident

  University Hospital of Patras

  STUDY DIRECTOR

Central Study Contacts

Konstantinos Katsanos, Professor

CONTACT

+306978225019; katsanos@med.upatras.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Interventional Radiology

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)