Completed

NCT Number: NCT06030232

Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

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.

Completed

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Key information

Conditions

Transarterial Radioembolization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University Medical School, Adana, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therasphere

Device

Transarterial radioembolization

Primary outcomes

effective tumor dose and safe healthy liver dose

Time frame: 3th month after treatment

Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.

Secondary outcomes

dose (in Gy) -response and dose (in Gy)-toxicity relationships

Time frame: 6th month after treatment

Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

Boston Scientific Corporation

Registry information

Acronym: TACOME

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 8, 2023
Registry last updated: Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.