Breast CancerNCT07627269
Late Scan Time-point Optimalisation of 18F-Fluoroestradiol for the Large Field-of-view (LAFOV) PET/CT Scanner.
A study testing Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Currently, in routine patient care PET/CT scan protocols used on high sensitivity large field of-view (LAFOV) PET/CT systems are based on protocols that historically were developed for standard field-of-view (SAFOV) PET/CT systems with a much lower sensitivity profile. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to 1 Aug 2030
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are referred for PET/CT imaging with 18F-Fluoroestradiol will be included in this study.
Who cannot join
- Patients who are not able to lay down in supine position for up to one hour.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9717GZ
Brouwers, +31 50 361 6161, a.h.brouwers@umcg.nl
About this study
Currently, in routine patient care PET/CT scan protocols used on high sensitivity large field of-view (LAFOV) PET/CT systems are based on protocols that historically were developed for standard field-of-view (SAFOV) PET/CT systems with a much lower sensitivity profile. In the current SAFOV-based imaging protocols, the maximum delay between injection and actual scanning is limited by increasing noise (due to radioactive decay) resulting in bad image quality. A major advantage of later time-point imaging in general is, that the target-to background ratio improves. With the high-sensitive LAFOV PET/CT scanner later time-point imaging becomes possible, and higher tumour-to background ratios can be obtained. Specifically for the 18F-Fluoroesradiol tracer, used to image estrogen receptor positive tumors, high physiological uptake in the liver and intestines hampers the visualization and quantification of liver metastases and peritoneal metastases. The aim of this study is to evaluate whether late time point imaging with the 18F-Fluoroestradiol tracer on the LAFOV PET/CT improves visualization and quantification of liver metastases and peritoneal metastases.
- Conditions
- Breast Cancer
- Being tested
- Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-FluoroestradiolRadiation
Patients who consent in participating will be scanned at one to two additional time-point(s) after injection, at a time-point that is later than the one currently used in practice.
| Study group | Role | What they receive |
|---|---|---|
| Extra PET/CT scan at 1 to 2 additional, later time-point(s) after injection than current practice | Experimental | Not described Receives: Radiation: Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the sensitivity/specificity of FES PET for liver metastases and peritoneal metastases, using conventional CT as gold standard.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627269
- Sponsor's protocol ID
- 23995
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Scan Time-point Optimalisation of 18F-Fluoroestradiol for the Large Field-of-view (LAFOV) PET/CT Scanner.
- ClinicalTrials.gov ID
- NCT07627269
- Acronym / sponsor ID
- 23995
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 4 Jun 2026 (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.
Currently, in routine patient care PET/CT scan protocols used on high sensitivity large field of-view (LAFOV) PET/CT systems are based on protocols that historically were developed for standard field-of-view (SAFOV) PET/CT systems with a much lower sensitivity profile. In the current SAFOV-based imaging protocols, the maximum delay between injection and actual scanning is limited by increasing noise (due to radioactive decay) resulting in bad image quality. A major advantage of later time-point imaging in general is, that the target-to background ratio improves. With the high-sensitive LAFOV PET/CT scanner later time-point imaging becomes possible, and higher tumour-to background ratios can be obtained. Specifically for the 18F-Fluoroesradiol tracer, used to image estrogen receptor positive tumors, high physiological uptake in the liver and intestines hampers the visualization and quantification of liver metastases and peritoneal metastases. The aim of this study is to evaluate whether late time point imaging with the 18F-Fluoroestradiol tracer on the LAFOV PET/CT improves visualization and quantification of liver metastases and peritoneal metastases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extra PET/CT scan at 1 to 2 additional, later time-point(s) after injection than current practice | Experimental | Radiation: Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are referred for PET/CT imaging with 18F-Fluoroestradiol will be included in this study.
Key exclusion criteria (1 listed)
- Patients who are not able to lay down in supine position for up to one hour.
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 |
|---|---|---|
| Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-FluoroestradiolPatients who consent in participating will be scanned at one to two additional time-point(s) after injection, at a time-point that is later than the one currently used in practice. | Radiation | Extra PET/CT scan at 1 to 2 additional, later time-point(s) after injection than current practice |
Primary outcome
The primary outcome measure is the sensitivity/specificity of FES PET for liver metastases and peritoneal metastases, using conventional CT as gold standard.
Time frame: Day 1
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 4 Jun 2026.
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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 Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the sensitivity/specificity of FES PET for liver metastases and peritoneal metastases, using conventional CT as gold standard. (time frame: Day 1). 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 4 Jun 2026.