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Completed

NCT Number: NCT06013774

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have given written informed consent and comply with the requirements of the study protocol.
  • Must be aged 18 years or over.
  • Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation treatment.
  • Sufficiently fit to undergo an additional examination time of 30-90 minutes.
  • Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation procedure.

Exclusion criteria

  • Patients expected to require more than two injection positions for radioembolisation treatment.
  • Pregnancy or nursing.
  • Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  • Patients who are declared incompetent.
  • Previous enrollment in the present study
  • Claustrophobia
  • The last dose of prior chemotherapy has been received less than weeks prior to the planned 99mTc-MAA pre-treatment procedure.
  • Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
  • Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
  • Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 2 from previous anti-cancer treatment
  • Body weight over 250 kg (because of maximum table load)
  • Patient length over 1.90 m (to fit IXSI geometry)
  • Patient bust line over 135 cm (to fit IXSI geometry)

Treatment and study plan

IXSI

Device

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

Primary outcomes

  1. Device Feasibility

    Time frame: Immediately after surgery

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

Secondary outcomes

  1. Radioactivity distribution over time

    Time frame: 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

    Time frame: Immediately after surgery

    The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: IXSI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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