RadioembolizationARTE-MISONCT06027021
Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET
An observational study of Radioembolization and Radiotherapy, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radioembolization, Radiotherapy, Cancer
- What is being tested?
- 18F-Fluoromisonidazole PET
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with ECOG performance score >1
- Claustrophobia
- Life expectancy shorter than 3 months
- Pregnant or breast-feeding patients
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 18F-Fluoromisonidazole PET
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoromisonidazole PETDiagnostic test
Imaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases Receives: Diagnostic Test: 18F-Fluoromisonidazole PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 08/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Aug 2023
- Primary completion15 May 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadioembolizationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
- Investigators
- Cigdem Soydal, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027021
- Sponsor's protocol ID
- ARTE-MISO
- Acronym
- ARTE-MISO
- Status last verified
- Jul 2024
- First submitted
- 31 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET
- ClinicalTrials.gov ID
- NCT06027021
- Acronym / sponsor ID
- ARTE-MISO / ARTE-MISO
- Conditions
- Radioembolization, Radiotherapy, Cancer, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Diagnostic Test: 18F-Fluoromisonidazole PETPatients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with ECOG performance score >1
- Claustrophobia
- Life expectancy shorter than 3 months
- Pregnant or breast-feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-Fluoromisonidazole PETImaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET. | Diagnostic test | Treatment group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Related trials for Radioembolization
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
RecruitingPhase 1
A Phase I Study of Intra-Arterial Yttrium-90 Radioembolization for Unresectable Pancreatic Cancer
Pancreatic Cancer Non-resectable
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
Not yet recruiting
An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
Recurrent Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cigdem Soydal, MD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radioembolization and Radiotherapy, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the effect of the hypoxia in the success of the radioembolization treatment (time frame: 08/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.