Liver CancerIXSINCT06013774
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
A study testing IXSI in people with Liver Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- IXSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2021to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization
- Conditions
- Liver Cancer
- Being tested
- IXSI
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXSIDevice
Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure
| Study group | Role | What they receive |
|---|---|---|
| Hybrid imaging during the pre-treatment procedure of radioembolization | Experimental | Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization Receives: Device: IXSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Feasibility
The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel
Measured: Immediately after surgery
Secondary outcomes (2)
Radioactivity distribution over time
The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior
Measured: Immediately after surgery
Radioactivity distribution in 3D
The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start25 May 2021
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo de Jong, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013774
- Sponsor's protocol ID
- NL71365.041.20
- Acronym
- IXSI
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dietze MMA, Meddens MBM, van Rooij R, Braat AJAT, de Keizer B, Bruijnen RCG, Lam MGEH, Smits MLJ, de Jong HWAM. Safety and Feasibility of Interventional Hybrid Fluoroscopy and Nuclear Imaging in the Work-up Procedure of Hepatic Radioembolization. Radiol Imaging Cancer. 2024 Nov;6(6):e240044. doi: 10.1148/rycan.240044.
PubMed 39485113
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
- ClinicalTrials.gov ID
- NCT06013774
- Acronym / sponsor ID
- IXSI / NL71365.041.20
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid imaging during the pre-treatment procedure of radioembolization | Experimental | Device: IXSIHybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXSIHybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure | Device | Hybrid imaging during the pre-treatment procedure of radioembolization |
Primary outcome
Device Feasibility
Time frame: Immediately after surgery
The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel
2 secondary outcomes
Radioactivity distribution over time
Time frame: Immediately after surgery
Radioactivity distribution in 3D
Time frame: Immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Derived from this study: PubMed 39485113Dietze MMA, Meddens MBM, van Rooij R, Braat AJAT, de Keizer B, Bruijnen RCG, Lam MGEH, Smits MLJ, de Jong HWAM. Safety and Feasibility of Interventional Hybrid Fluoroscopy and Nuclear Imaging in the Work-up Procedure of Hepatic Radioembolization. Radiol Imaging Cancer. 2024 Nov;6(6):e240044. doi: 10.1148/rycan.240044.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IXSI in people with Liver Cancer, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.