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

NCT06013774 | Completed

• 1 other identifier: NL71365.041.20
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Device Feasibility

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

  Immediately after surgery

Secondary Outcomes (2)

• Radioactivity distribution over time

  Immediately after surgery

• Radioactivity distribution in 3D

  Immediately after surgery

Study Arms (1)

Hybrid imaging during the pre-treatment procedure of radioembolization

EXPERIMENTAL

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

Device: IXSI

Interventions

IXSI DEVICE

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

Hybrid imaging during the pre-treatment procedure of radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39485113 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 28, 2023
• Study Start: May 25, 2021
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

NL (1)