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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06027021
Other study ID # ARTE-MISO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2023
Est. completion date November 15, 2024

Study information

Verified date September 2023
Source Ankara University
Contact Cigdem Soydal, MD
Phone 903125956445
Email csoydal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial radioembolization is known to be variable between different patients even if the same dose of radiation was delivered. In this study the investigators aim to quantify the hypoxia in the primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to ensure treatment response.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date November 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma. - Is not eligible for surgery - Above 18 years old - The patients who are referred for transarterial radioembolization treatment to Ankara University School of Medicine Department of Nuclear Medicine. Exclusion Criteria: - Patients with ECOG performance score >1 - Claustrophobia - Life expectancy shorter than 3 months - Pregnant or breast-feeding patients

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
18F-Fluoromisonidazole PET
Imaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET.

Locations

Country Name City State
Turkey Ankara University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demonstrate the effect of the hypoxia in the success of the radioembolization treatment Demonstrate the effect of the hypoxia in the success of the radioembolization treatment 08/2024
Primary The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group. The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group. 08/2024
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