Breast CancerPhase 1/2NCT04150731
16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
A Phase 1/2 study testing 16α-18F-fluor-17β-estradiol in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 16α-18F-fluor-17β-estradiol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Oct 2020to 28 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known disseminated breast cancer
- Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate liver foci visualised on CT
- Diagnostic CT scan done in connection with clinical control
- Treatment with aromatase inhibitors, and potential additional treatment
- Postmenopausal
Who cannot join
- Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES-PET/CT
- ER- metastases
- Life expectancy under three months
- Claustrophobia
- Any pain which makes it impossible to lie in the scanner for 90 minutes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: 16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft
Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. The ER expression can change over time and be heterogeneous.
The IHC score on ER expression is subjective and can lead to intra and inter observer variability. A new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed.
Read more
It is also possible to quantify the ER expression non invasive by using the tracer 16α-18F-flour-17β-estradiol (FES) and in vivo positron emission tomography (PET) scans. FES-PET/CT has a high background activity in the liver which complicates the visualization of liver metastases. Theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases.
Malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (DFS). To the best of our knowledge, no previous studies have examined the correlation between ER expression and blood flow.
- Conditions
- Breast Cancer
- Being tested
- 16α-18F-fluor-17β-estradiol
- Keywords
- Breast cancer, Liver metastases, FES-PET/CT, Dynamic scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16α-18F-fluor-17β-estradiolRadiation
16α-18F-fluor-17β-estradiol PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer and FES | Experimental | Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done Receives: Radiation: 16α-18F-fluor-17β-estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of parametric FES-PET/CT
Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases
Measured: 1 year
Secondary outcomes (5)
Correlation of ER expression
Correlate the ER expression in metastases measured by parametric FES-PET/CT to Visiopharm H-score on biopsy material examined by immunohistochemistry (IHC)
Measured: 1 year
Examination of the heterogeneity of ER expression in liver metastases
Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT
Measured: 1 year
Examination of the heterogeneity of ER expression i metastases
Examine intra-individual heterogeneity of ER expression in metastases in different tissues by FES-PET/CT
Measured: 1 year
Examination of the heterogeneity of ER expression
Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT
Measured: 1 year
Correlation of tumor blood flow to ER+ cells
Correlate tumor blood flow measured by H215O-PET/CT to the percentage of ER+ cells, measured by both FES-PET/CT and Visiopharm technology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start23 Oct 2020
- Primary completion25 Oct 2022
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap
- Responsible party
- Sponsor
- Investigators
- Mette A Pedersen, MD, Principal investigator, Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150731
- Sponsor's protocol ID
- 2020FES
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen MA, Munk OL, Dias AH, Steffensen JH, Moller AL, Johnsson AL, Hansen KV, Bender D, Jakobsen S, Busk M, Gormsen LC, Tramm T, Borgquist S, Vendelbo MH. Dynamic whole-body [18F]FES PET/CT increases lesion visibility in patients with metastatic breast cancer. EJNMMI Res. 2024 Mar 4;14(1):24. doi: 10.1186/s13550-024-01080-y.
PubMed 38436824
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft
- ClinicalTrials.gov ID
- NCT04150731
- Acronym / sponsor ID
- 2020FES
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Liver metastases, FES-PET/CT, Dynamic scan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 5 Nov 2019 (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.
Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. The ER expression can change over time and be heterogeneous.
The IHC score on ER expression is subjective and can lead to intra and inter observer variability. A new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed.
It is also possible to quantify the ER expression non invasive by using the tracer 16α-18F-flour-17β-estradiol (FES) and in vivo positron emission tomography (PET) scans. FES-PET/CT has a high background activity in the liver which complicates the visualization of liver metastases. Theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases.
Malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (DFS). To the best of our knowledge, no previous studies have examined the correlation between ER expression and blood flow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer and FES | Experimental | Radiation: 16α-18F-fluor-17β-estradiolOnly one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with known disseminated breast cancer
- Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate liver foci visualised on CT
- Diagnostic CT scan done in connection with clinical control
- Treatment with aromatase inhibitors, and potential additional treatment
- Postmenopausal
Key exclusion criteria (5 listed)
- Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES-PET/CT
- ER- metastases
- Life expectancy under three months
- Claustrophobia
- Any pain which makes it impossible to lie in the scanner for 90 minutes
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 |
|---|---|---|
| 16α-18F-fluor-17β-estradiol16α-18F-fluor-17β-estradiol PET/CT scan | Radiation | Breast cancer and FES |
Primary outcome
Sensitivity of parametric FES-PET/CT
Time frame: 1 year
Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases
5 secondary outcomes
Correlation of ER expression
Time frame: 1 year
Examination of the heterogeneity of ER expression in liver metastases
Time frame: 1 year
Examination of the heterogeneity of ER expression i metastases
Time frame: 1 year
Examination of the heterogeneity of ER expression
Time frame: 1 year
Correlation of tumor blood flow to ER+ cells
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 38436824Pedersen MA, Munk OL, Dias AH, Steffensen JH, Moller AL, Johnsson AL, Hansen KV, Bender D, Jakobsen S, Busk M, Gormsen LC, Tramm T, Borgquist S, Vendelbo MH. Dynamic whole-body [18F]FES PET/CT increases lesion visibility in patients with metastatic breast cancer. EJNMMI Res. 2024 Mar 4;14(1):24. doi: 10.1186/s13550-024-01080-y.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mette A Pedersen, MD principal investigator
Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 16α-18F-fluor-17β-estradiol in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Dec 2023. 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 Denmark. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of parametric FES-PET/CT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150731, which also lists 1 linked publication.
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 Dec 2023.