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

Not Applicable

Completed

• Conditions: Liver Cancer
• Interventions: Device: IXSI

• Registration Number: NCT06013774
• Lead Sponsor: UMC Utrecht

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Primary Completion: 2023-01-16
• Study Completion: 2023-01-16
• Study First Submitted: 2023-07-06
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid imaging during the pre-treatment procedure of radioembolization	IXSI	Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization

Primary Outcome Measures

Name	Time	Method
Device Feasibility	Immediately after surgery	The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel

Secondary Outcome Measures

Name	Time	Method
Radioactivity distribution over time	Immediately after surgery	The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior
Radioactivity distribution in 3D	Immediately after surgery	The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands