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Clinical Trials/NCT06030232
NCT06030232
Completed
Not Applicable

Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

Ankara University8 sites in 1 country202 target enrollmentJanuary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transarterial Radioembolization
Sponsor
Ankara University
Enrollment
202
Locations
8
Primary Endpoint
effective tumor dose and safe healthy liver dose
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
April 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cigdem Soydal

Asc. Prof. of Nuclear Medicine, MD, FEBNM

Ankara University

Eligibility Criteria

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

Outcomes

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(6th month after treatment)

Study Sites (8)

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