Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure

Study Overview
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Brief Summary
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To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization

Official Title
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Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure

Conditions
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Liver Cancer

Intervention / Treatment
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* Device: IXSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have given written informed consent and comply with the requirements of the study protocol. Must be aged 18 years or over. Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation treatment. Sufficiently fit to undergo an additional examination time of 30-90 minutes. Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation procedure. Exclusion Criteria: Patients expected to require more than two injection positions for radioembolisation treatment. Pregnancy or nursing. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. Patients who are declared incompetent. Previous enrollment in the present study Claustrophobia The last dose of prior chemotherapy has been received less than weeks prior to the planned 99mTc-MAA pre-treatment procedure. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 2 from previous anti-cancer treatment Body weight over 250 kg (because of maximum table load) Patient length over 1.90 m (to fit IXSI geometry) Patient bust line over 135 cm (to fit IXSI geometry)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid imaging during the pre-treatment procedure of radioembolization<br>Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization | Device: IXSI<br>* Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Feasibility | The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity distribution over time | The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior | Immediately after surgery | 
| Radioactivity distribution in 3D | The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D | Immediately after surgery |