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TACOME: Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

Sponsor
Ankara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06030232
Collaborator
Boston Scientific Corporation (Industry)
350
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Therasphere

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Jun 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Observation group

Patients who received radioembolization for colorectal cancer liver metastases

Device: Therasphere
Transarterial radioembolization

Outcome Measures

Primary Outcome Measures

  1. 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

  1. dose (in Gy) -response and dose (in Gy)-toxicity relationships [6th month after treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ankara University
  • Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cigdem Soydal, Asc. Prof. of Nuclear Medicine, MD, FEBNM, Ankara University
ClinicalTrials.gov Identifier:
NCT06030232
Other Study ID Numbers:
  • TACOME-TR
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Sep 8, 2023