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

Sponsor
Ankara University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06027021
Collaborator
(none)
64
Enrollment
1
Location
15
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Diagnostic Test: 18F-Fluoromisonidazole PET

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 15, 2023
Anticipated Primary Completion Date :
May 15, 2024
Anticipated Study Completion Date :
Nov 15, 2024

Arms and Interventions

Arm 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

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Ankara University Ankara Turkey 06590

Sponsors and Collaborators

  • Ankara University

Investigators

  • Principal Investigator: Cigdem Soydal, MD, Ankara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cigdem Soydal, Asc Prof, Ankara University
ClinicalTrials.gov Identifier:
NCT06027021
Other Study ID Numbers:
  • ARTE-MISO
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypoxia

Study Results

No Results Posted as of Sep 11, 2023