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Completed

NCT Number: NCT06027021

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University

Ankara, 06590, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-Fluoromisonidazole PET

Diagnostic Test

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

Primary outcomes

  1. Demonstrate the effect of the hypoxia in the success of the radioembolization treatment

    Time frame: 08/2024

    Demonstrate the effect of the hypoxia in the success of the radioembolization treatment

  2. The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.

    Time frame: 08/2024

    The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Acronym: ARTE-MISO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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