Introduction of Y90-PET-CT Post Radioembolisation Therapy Scans (Y90-PET-CT)

November 7, 2023 updated by: The Christie NHS Foundation Trust

Introduction to the Clinical Workflow of Y90-PET-CT Post-therapy Scans to Patients Undergoing Y90-microspheres Radioembolisation Therapy

Yttrium-90, attached to microspheres, usually referred to as 90Y-microspheres or Y-90 radioembolisation, can be used in some cases to treat patients with liver tumours or liver metastasis. The treatment aim is to infuse the 90Ymicrospheres into the patient's liver. The microspheres get trapped in the lesions of micro-blood vessels while the yttrium-90, a radioactive compound, delivers radiation doses locally at these sites and damages the diseased cells.

Therapy is performed in such a way the 90Y-microspheres are localised in the tumour areas minimising damage to the healthy liver tissue. This treatment requires many steps involving professionals from different medical disciplines.

Patients are scanned in the nuclear Medicine Department on a gamma camera the day after the treatment. This scan is referred as Y-90 bremsstrahlung-SPECT. This posttherapy scan provides a 3-dimensional (3D) image of the distribution of the therapeutic agent in the patient's abdomen so an assessment of how much of the therapeutic agent has gone to the sites of disease can be performed.

In this research project, the investigators would like to evaluate an alternative post-therapy scan to the one routinely performed on the gamma camera. The alternative scan is done on a PET-CT scanner and is referred to as Y90-PET-CT. This type of scan has been reported to provide improved quality images, providing more accurate information on the distribution of the patients therapeutic dose.

For this research project, the investigators will invite a small number of patients undergoing this therapy to be scanned twice after treatment: with the current post-therapy scan on a gamma camera; and with the newly proposed scan method, Y90-PET-CT. Depending on the outcomes of this project, assessed by an expert panel of radiologists and medical physicists, the investigators will determine whether we will introduce this new scanning method into clinical practice in the future.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on patients with liver cancer and/or liver metastasis, referred to as 90Y-microspheres radiation therapy or Y-90 radioembolisation. There will be 10 patients recruited. No further radioisotope administration will be performed (please refer to section 7 for full eligibility criteria).

Primary Outcome - Introduce and optimise a Y90-PET-CT protocol post-therapy scan for patients undergoing 90Y-radioembolisation treatment. The Y90-PET-CT scan will be used primarily to confirm the radiotracer delivery to the target lesions. A Y90-PET-CT scan is believed to provide improved quality images compared to a Y90-bremsstrahlung-SPECT scan; hence, more accurate information on the success/failure of the therapy is expected to be obtained when using Y90-PET-CT images.

Secondary Outcomes - Introduce in the department post-therapy dosimetry for Y90-microspheres radioembolisation using the optimised 90Y-PET-CT images obtained from the primary objective. This work will be done following published guidelines for post-therapy dosimetry and using pre-existing and bespoke commercial software applications that perform this task.

The investigators expect the images resulting from 90Y-PET-CT will provide better information about the success or not of the infusion of the 90Y-microspheres into the target areas. 90Y-PET-CT will, in turn, provide a better understanding of post-therapy scans in our department, better management of 90Y-radioembolization patients and the development of improved radioembolization treatment-planning models in the future.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing liver treatment Y90-Microspheres therapy.
  • Male or female
  • Aged 18-85 years

Exclusion Criteria:

A participant will not be eligible for inclusion in this study if any of the following criteria apply:

  • History of, or suffers from, claustrophobia or participant feels unable to lie flat and still on their back for a period of up to 45 minutes in the scanner;

    o Priority will be given to their current clinical care scan Y-90-bremsstrahlung-SPECT

  • In the opinion of the clinical team, they are unlikely to comply with the study protocol and restrictions that it imposes (i.e. patient uncomfortable to withstand a double scan on the day); Female participants of childbearing potential must confirm they are not pregnant (a strict requisite before 90Y-therapy anyway).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arms
Single arm study
Device: Y90-PET-CT scan
40 min extra PET-CT scan - no extra injection of radiotracer. We image the Y90-microspheres administered to these patients during the therapy
Other Names:
  • Y90-PET-CT protocol post-therapy scan for patients undergoing 90Y-microspheres or 90Y-radioembolization treatment or SIRT at the Christie NHS Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical comparison of current post-therapy scans, Y-90-bremsstrahlung-SPECT, with 90Y-PET-CT for a cohort of 10 patients assessing the feasibility of performing only 90Y-PET-CT post-therapy in the future.
Time Frame: 12 months
The success criterion of this project will be whether the investigators can incorporate 90Y-PET-CT scans in the department in the future. This will be done by directly comparing 90Y-PET-CT scans with Y-90-bremsstrahlung-SPECT images for each patient and also considering the impact of introducing additional PET-CT scans into the clinical workflow in a very busy Nuclear Medicine department.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ChristieNHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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