Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver

NCT06030232 | Completed FDA Device

• 1 other identifier: TACOME-TR
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 8

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.

Conditions

Transarterial Radioembolization

Outcome Measures

Primary Outcomes (1)

• effective tumor dose and safe healthy liver dose

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

  3th month after treatment

Secondary Outcomes (1)

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

  6th month after treatment

Study Arms (1)

Observation group

Patients who received radioembolization for colorectal cancer liver metastases

Device: Therasphere

Interventions

Therasphere DEVICE

Transarterial radioembolization

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead
• Boston Scientific Corporation: collaborator

Study Sites (8)

Cukurova University Medical School

Adana, Turkey (Türkiye)

Location

Ankara University Medical School

Ankara, Turkey (Türkiye)

Location

Hacettepe Univeristy Medical School

Ankara, Turkey (Türkiye)

Location

Istanbul University Capa Medical School

Istanbul, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical School

Istanbul, Turkey (Türkiye)

Location

Marmara University Medical School

Istanbul, Turkey (Türkiye)

Location

Yeditepe University Medical School

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University Medical School

Izmir, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asc. Prof. of Nuclear Medicine, MD, FEBNM

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: January 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

TU (8)