Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

Completed

• Conditions: Transarterial Radioembolization
• Interventions: Device: Therasphere

• Registration Number: NCT06030232
• Lead Sponsor: Ankara University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-08
• Study Start: 2024-01-15
• Primary Completion: 2024-03-15
• Status Verified: 2024-04
• Study Completion: 2024-04-15
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation group	Therasphere	Patients who received radioembolization for colorectal cancer liver metastases

Primary Outcome Measures

Name	Time	Method
effective tumor dose and safe healthy liver dose	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 Outcome Measures

Name	Time	Method
dose (in Gy) -response and dose (in Gy)-toxicity relationships	6th month after treatment	Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.

Trial Locations

Locations (8)

Ankara University Medical School; 🇹🇷 Ankara, Turkey

Dokuz Eylul University Medical School; 🇹🇷 İzmir, Turkey

Cukurova University Medical School; 🇹🇷 Adana, Turkey

Hacettepe Univeristy Medical School; 🇹🇷 Ankara, Turkey

Istanbul University Capa Medical School; 🇹🇷 Istanbul, Turkey

Istanbul University Cerrahpasa Medical School; 🇹🇷 Istanbul, Turkey

Marmara University Medical School; 🇹🇷 Istanbul, Turkey

Yeditepe University Medical School; 🇹🇷 Istanbul, Turkey