Introduction of Y90-PET-CT Post Radioembolisation Therapy Scans

NCT06123676 | Recruiting

• 1 other identifier: ChristieNHS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

Single arms

OTHER

Single arm study

Device: Y90-PET-CT scan

Interventions

Y90-PET-CT scan DEVICE

40 min extra PET-CT scan - no extra injection of radiotracer. We image the Y90-microspheres administered to these patients during the therapy

Also known as: Y90-PET-CT protocol post-therapy scan for patients undergoing 90Y-microspheres or 90Y-radioembolization treatment or SIRT at the Christie NHS Hospital

Single arms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS - Nuclear Medicine Department

Manchester, M204BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Heather Williams

CONTACT

01619187118; heather.williams34@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 9, 2023
• Study Start: October 9, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

GB (1)