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Trial record 5 of 5 for:    fmiso pet hcc
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Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET (ARTE-MISO)

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ClinicalTrials.gov Identifier: NCT06027021
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Cigdem Soydal, Ankara University

Study Description
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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.

Condition or disease Intervention/treatment
Radioembolization Radiotherapy Cancer Positron Emission Tomography Diagnostic Test: 18F-Fluoromisonidazole PET

Study Design
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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : November 15, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment group
Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases
 Diagnostic Test: 18F-Fluoromisonidazole PET
Imaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The patients with hepatocellular carcinoma or colorectal carcinoma with liver metastasis who are referred for transarterial radioembolization to Ankara University School of Medicine Department of Nuclear Medicine will be enrolled for the trial.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06027021


Contacts
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Contact: Cigdem Soydal, MD 903125956445 csoydal@yahoo.com

Locations
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Turkey
Ankara University Recruiting
Ankara, Turkey, 06590
Contact: Cigdem Soydal, MD    903125956445    csoydal@yahoo.com   
Principal Investigator: Cigdem Soydal, MD         
Sponsors and Collaborators
Ankara University
Investigators
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Principal Investigator: Cigdem Soydal, MD Ankara University
More Information
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Responsible Party: Cigdem Soydal, Asc Prof, Ankara University
ClinicalTrials.gov Identifier: NCT06027021    
Other Study ID Numbers: ARTE-MISO
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory