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

UMC Utrecht

Status: Completed

Conditions: Liver Cancer

Treatments: Device: IXSI

Study type: Interventional

Funder types: Other

Identifiers

NCT06013774

NL71365.041.20

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must have given written informed consent and comply with the requirements 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 radioembolisation 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 pre-treatment radioembolisation procedure.

Exclusion criteria

1. Patients expected to require more than two injection positions for radioembolisation 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 weeks prior to the planned 99mTc-MAA pre-treatment procedure.
8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) 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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Hybrid imaging during the pre-treatment procedure of radioembolization

Experimental group

Description:

Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization

Treatment:

Device: IXSI