Breast CancerNCT05613270
Characterizing Breast Cancer With 18F-FES PET/CT
A study testing 18F-FES PET/CT scan in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 18F-FES PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2024
- Phase
- Interventional
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed metastatic ER-positive breast cancer;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Who cannot join
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhixin Hao, M.D., +86-18401649136, zxhaonm@outlook.com
Li Huo, M.D., +86-13910801986, huoli@pumch.cn
About this study
Official title: A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- 18F-FES PET/CT 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.
18F-FES PET/CT scanDiagnostic test
Patients with suspected metastatic ER-positive breast cancer underwent 18F-FES PET/CT after an injection of 185-222 MBq (5-6 mCi) 18F-FES to image lesions of metastatic breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FES PET/CT | Experimental | Inject 18F-FES and then perform PET/CT scan. Receives: Diagnostic Test: 18F-FES PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 18F-FES in BC
The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
Measured: through study completion, an average of 1 year
Lesions detected by 18F-FES PET/CT
The number of target lesions was calculated by 18F-FES PET/CT.
Measured: through study completion, an average of 1 year
Compared with 18F-FDG PET/CT
The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Overall survival
Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Peking Union Medical College HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613270
- Sponsor's protocol ID
- PekingUMCH-FES-BC-1
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao R, Qu Y, Hao Z, Xu Y, Zhang J, Lian J, Gao L, Shen S, Mao F, Pan B, Sun Q, Huo L, Zhou Y. Rationale and Trial Design of DAWNA-FES Trial: Single-Arm Phase II Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [18F]FES PET/CT in Patients With HR+/HER2- Advanced Breast Cancer. Cancer Innov. 2026 Apr 30;5(3):e70058. doi: 10.1002/cai2.70058. eCollection 2026 Jun.
PubMed 42078117
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05613270
- Acronym / sponsor ID
- PekingUMCH-FES-BC-1
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Nov 2022 (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.
18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FES PET/CT | Experimental | Diagnostic Test: 18F-FES PET/CT scanInject 18F-FES and then perform PET/CT scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suspected or confirmed metastatic ER-positive breast cancer;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Key exclusion criteria (3 listed)
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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 |
|---|---|---|
| 18F-FES PET/CT scanPatients with suspected metastatic ER-positive breast cancer underwent 18F-FES PET/CT after an injection of 185-222 MBq (5-6 mCi) 18F-FES to image lesions of metastatic breast cancer. | Diagnostic test | 18F-FES PET/CT |
Primary outcome
Standardized uptake value of 18F-FES in BC
Time frame: through study completion, an average of 1 year
The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
Lesions detected by 18F-FES PET/CT
Time frame: through study completion, an average of 1 year
The number of target lesions was calculated by 18F-FES PET/CT.
Compared with 18F-FDG PET/CT
Time frame: through study completion, an average of 1 year
The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 42078117Yao R, Qu Y, Hao Z, Xu Y, Zhang J, Lian J, Gao L, Shen S, Mao F, Pan B, Sun Q, Huo L, Zhou Y. Rationale and Trial Design of DAWNA-FES Trial: Single-Arm Phase II Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [18F]FES PET/CT in Patients With HR+/HER2- Advanced Breast Cancer. Cancer Innov. 2026 Apr 30;5(3):e70058. doi: 10.1002/cai2.70058. eCollection 2026 Jun.
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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.
Li Huo, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FES PET/CT scan in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhixin Hao, M.D. (+86-18401649136, zxhaonm@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value of 18F-FES in BC (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT05613270, 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 14 Nov 2022.