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IXSI: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA during the radioembolisation pretreatment procedure

IXSI: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA during the radioembolisation pretreatment procedure - IXSI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55138
Enrollment
15
Registered
2021-02-12
Start date
2021-05-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver tumor

Interventions

Angiographic work-up will be identical to the standard procedure up to the point of 99mTc-MAA injection. Then, 2D imaging of the controlled injection of 99mTc-MAA using IXSI is performed, followed b

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 4 weeks prior to the planned 99mTc-MAA pretreatment procedure. 8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pretreatment 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 1) 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)

Design outcomes

Primary

MeasureTime frame
Safety of the use of IXSI in an interventional setting.

Secondary

MeasureTime frame
Comparison of dosimetry (lung shunt fraction (LSF), tumour to non-tumour ratio (T/N ratio) and dose to liver segments) based on IXSI and conventional SPECT/CT. Visual inspection of 2D images of 99mTc-MAA administration.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)