Status:
COMPLETED
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
Lead Sponsor:
UMC Utrecht
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06013774
Start Date
May 25 2021
End Date
January 16 2023
Last Update
August 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMC Utrecht
Utrecht, Netherlands