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

Liver Cancer Clinical Trial

— IXSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06013774
• Other study ID #: NL71365.041.20
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: January 16, 2023

Study information

• Verified date: August 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• IXSI
Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Feasibility	The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel	Immediately after surgery
Secondary	Radioactivity distribution over time	The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior	Immediately after surgery
Secondary	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