CancerY90-PET-CTNCT06123676
Introduction of Y90-PET-CT Post Radioembolisation Therapy Scans
A study testing Y90-PET-CT scan in people with Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Y90-PET-CT scan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing liver treatment Y90-Microspheres therapy.
- Male or female
- Aged 18-85 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS - Nuclear Medicine Department
Manchester, M204BX
Heather Williams, PhD, 01619187118, heather.williams34@nhs.net
Jose M Anton Rodriguez, PhD, 01619187118, Jose.antonrodriguez@nhs.net
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Y90-PET-CT scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y90-PET-CT scanDevice
Also called Y90-PET-CT protocol post-therapy scan for patients undergoing 90Y-microspheres or 90Y-radioembolization treatment or SIRT at the Christie NHS Hospital
40 min extra PET-CT scan - no extra injection of radiotracer. We image the Y90-microspheres administered to these patients during the therapy
| Study group | Role | What they receive |
|---|---|---|
| Single arms | Other | Single arm study Receives: Device: Y90-PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start9 Oct 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123676
- Sponsor's protocol ID
- ChristieNHS
- Acronym
- Y90-PET-CT
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction to the Clinical Workflow of Y90-PET-CT Post-therapy Scans to Patients Undergoing Y90-microspheres Radioembolisation Therapy
- ClinicalTrials.gov ID
- NCT06123676
- Acronym / sponsor ID
- Y90-PET-CT / ChristieNHS
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Nov 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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arms | Other | Device: Y90-PET-CT scanSingle arm study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing liver treatment Y90-Microspheres therapy.
- Male or female
- Aged 18-85 years
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Y90-PET-CT scanAlso: Y90-PET-CT protocol post-therapy scan for patients undergoing 90Y-microspheres or 90Y-radioembolization treatment or SIRT at the Christie NHS Hospital40 min extra PET-CT scan - no extra injection of radiotracer. We image the Y90-microspheres administered to these patients during the therapy | Device | Single arms |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y90-PET-CT scan in people with Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Williams (01619187118, heather.williams34@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.