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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2023-01-16

Brief Summary

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

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Detailed Description

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Conditions

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Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Hybrid imaging during the pre-treatment procedure of radioembolization

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

Group Type EXPERIMENTAL

IXSI

Intervention Type DEVICE

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

Interventions

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IXSI

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

Intervention Type DEVICE

Eligibility Criteria

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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

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 weeks prior to the planned 99mTc-MAA pre-treatment procedure.
8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No