Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

NCT ID: NCT06030232

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-04-15

Brief Summary

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Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.

Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.

Detailed Description

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Conditions

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Transarterial Radioembolization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observation group

Patients who received radioembolization for colorectal cancer liver metastases

Therasphere

Intervention Type DEVICE

Transarterial radioembolization

Interventions

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Therasphere

Transarterial radioembolization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* over 18 years old
* histopathologically proven colorectal cancer diagnosis
* treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
* have follow-up data at least 6 months after radioembolization

Exclusion Criteria

* no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.

No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Cigdem Soydal

Asc. Prof. of Nuclear Medicine, MD, FEBNM

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University Medical School

Adana, , Turkey (Türkiye)

Site Status

Ankara University Medical School

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Univeristy Medical School

Ankara, , Turkey (Türkiye)

Site Status

Istanbul University Capa Medical School

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa Medical School

Istanbul, , Turkey (Türkiye)

Site Status

Marmara University Medical School

Istanbul, , Turkey (Türkiye)

Site Status

Yeditepe University Medical School

Istanbul, , Turkey (Türkiye)

Site Status

Dokuz Eylul University Medical School

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TACOME-TR

Identifier Type: -

Identifier Source: org_study_id

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