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Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET

Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06027021
Acronym
ARTE-MISO
Enrollment
64
Registered
2023-09-07
Start date
2023-08-15
Completion date
2024-07-15
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Positron Emission Tomography, Radioembolization, Radiotherapy

Brief 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.

Interventions

DIAGNOSTIC_TEST18F-Fluoromisonidazole PET

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

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Demonstrate the effect of the hypoxia in the success of the radioembolization treatment08/2024Demonstrate the effect of the hypoxia in the success of the radioembolization treatment
The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.08/2024The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026