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

• Sponsor: UMC Utrecht (Other)
• Overall Status: Completed
• CT.gov ID: NCT06013774
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer	Device: IXSI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
• Actual Study Start Date: May 25, 2021
• Actual Primary Completion Date: Jan 16, 2023
• Actual Study Completion Date: Jan 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid imaging during the pre-treatment procedure of radioembolization Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization	Device: IXSI; Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure

Outcome Measures

Primary Outcome Measures

1. Device Feasibility [Immediately after surgery]

   The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel

Secondary Outcome Measures

1. Radioactivity distribution over time [Immediately after surgery]

   The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMC Utrecht	Utrecht		Netherlands

Sponsors and Collaborators

• UMC Utrecht

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hugo de Jong, Principal Investigator, UMC Utrecht
• ClinicalTrials.gov Identifier: NCT06013774
• Other Study ID Numbers: NL71365.041.20
• First Posted: Aug 28, 2023
• Last Update Posted: Aug 28, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

No Results Posted as of Aug 28, 2023