IXSI safety study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

Participants will be recruited from patients, which are clinically selected to undergo a radioembolisation treatment at the UMC Utrecht. This will be adult men and women with liver tumour(s), that have no curative treatment options. The patient’s indication for hepatic radioembolisation will be discussed in a multidisciplinary tumour board.

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1.Participants must have given written informed consent and comply with the re-quirements of the study protocol.
2.Must be aged 18 years or over.
3.Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisa-tion treatment.
4.Sufficiently fit to undergo an additional examination time of 30-90 minutes.
5.Have a CT acquired less than 6 weeks before the pretreatment radioembolisation procedure.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1.Patients expected to require more than two injection positions for radioembolisa-tion treatment.
2.Pregnancy or nursing.
3.Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
4.Patients who are declared incompetent.
5.Previous enrollment in the present study
6.Claustrophobia
7.The last dose of prior chemotherapy has been received less than 4 weeks prior to the planned 99mTc-MAA pretreatment procedure.
8.Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pretreat-ment procedure
9.Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pretreatment procedure
10.Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5, see appendix A) grade 2 from previous anti-cancer treatment
11.Body weight over 250 kg (because of maximum table load)
12.Patient length over 1.90 m (to fit IXSI geometry)
13.Patient bust line over 135 cm (to fit IXSI geometry)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective: <br>•To establish the safety of acquiring 2D and 3D hybrid images using IXSI in an interventional setting.

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives: <br>•To establish the clinical usability of dosimetry based on interventional SPECT/CBCT using IXSI compared to traditional SPECT/CT based dosimetry after the pretreatment procedure.<br>•To image the (hemo-)dynamic processes influencing the microsphere distribution during the administration of 99mTc-MAA, using IXSI.