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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
IXSI
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid imaging during the pre-treatment procedure of radioembolization

Arm Description

Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radioactivity distribution over time
The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior
Radioactivity distribution in 3D
The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D

Full Information

First Posted
July 6, 2023
Last Updated
August 24, 2023
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT06013774
Brief Title
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
Acronym
IXSI
Official Title
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid imaging during the pre-treatment procedure of radioembolization
Arm Type
Experimental
Arm Description
Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization
Intervention Type
Device
Intervention Name(s)
IXSI
Intervention Description
Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure
Primary Outcome Measure Information:
Title
Device Feasibility
Description
The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel
Time Frame
Immediately after surgery
Secondary Outcome Measure Information:
Title
Radioactivity distribution over time
Description
The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior
Time Frame
Immediately after surgery
Title
Radioactivity distribution in 3D
Description
The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D
Time Frame
Immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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