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

NCT06027021 | Completed

• 1 other identifier: ARTE-MISO
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Radioembolization; Radiotherapy; Cancer; Positron Emission Tomography

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treatment group

Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases

Diagnostic Test: 18F-Fluoromisonidazole PET

Interventions

18F-Fluoromisonidazole PET DIAGNOSTIC_TEST

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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with ECOG performance score \>1
• Claustrophobia
• Life expectancy shorter than 3 months
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06590, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cigdem Soydal, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asc Prof

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: August 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

TU (1)