Breast CancerNCT07859046
18F-FES PET/CT in the Treatment Planning, and Response Assessment of ER-Positive Breast Cancer
An observational study of Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This study uses FES PET/CT imaging to evaluate estrogen receptor-positive breast cancer. FES PET/CT is a type of imaging that can show whether breast cancer cells have estrogen receptors. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2024to 31 Dec 2028
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with suspected or new diagnosed or previously treated ER-positive breast cancer.
Who may be able to join
- (1) adult female patients aged ≥18 years; (2) ER-positive breast cancer confirmed by pathological biopsy; (3) underwent initial staging with18F-FES PET/CT scans.
Who cannot join
- (1)patients with more than two primary tumors; (2) incomplete clinical or pathological records; and (3) inability to complete imaging studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 18F-FES PET/CT in the Diagnosis, Treatment Planning, and Response Assessment of ER-Positive Breast Cancer
This study uses FES PET/CT imaging to evaluate estrogen receptor-positive breast cancer. FES PET/CT is a type of imaging that can show whether breast cancer cells have estrogen receptors. The purpose of this study is to see how well FES PET/CT can help doctors: (1) diagnose ER-positive breast cancer, (2) plan the best treatment, and (3) check how well treatment is working. Participants will undergo FES PET/CT scans as part of their regular cancer care or study procedures. The results may help improve how doctors use imaging to guide treatment decisions for patients with ER-positive breast cancer.
Read the detailed description
Estrogen receptor (ER) status is a critical determinant of treatment strategy in breast cancer. While 18F-FDG PET/CT is widely used for metabolic assessment, it cannot directly visualize ER expression. 18F-FES is a radiolabeled estrogen analog that binds specifically to ER, enabling non-invasive visualization and quantification of ER expression in vivo. The combined use of 18F-FDG and 18F-FES PET/CT may provide complementary metabolic and receptor information for diagnosis, treatment planning, and therapeutic response assessment in ER-positive breast cancer.This study aims to evaluate the clinical utility of FES PET/CT in three domains: (1) diagnosis and characterization of ER-positive breast cancer lesions, (2) informing treatment planning by assessing ER expression heterogeneity, and (3) monitoring treatment response through quantitative changes in FES uptake.
- Conditions
- Breast Cancer
- Keywords
- FES, ER-positive, breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FES PET/CT were calculated.
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 Oct 2026
- Study start9 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859046
- Sponsor's protocol ID
- 2026-107
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FES PET/CT in the Diagnosis, Treatment Planning, and Response Assessment of ER-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07859046
- Acronym / sponsor ID
- 2026-107
- Conditions
- Breast Cancer
- Keywords
- FES, ER-positive, breast cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Oct 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.
This study uses FES PET/CT imaging to evaluate estrogen receptor-positive breast cancer. FES PET/CT is a type of imaging that can show whether breast cancer cells have estrogen receptors. The purpose of this study is to see how well FES PET/CT can help doctors: (1) diagnose ER-positive breast cancer, (2) plan the best treatment, and (3) check how well treatment is working. Participants will undergo FES PET/CT scans as part of their regular cancer care or study procedures. The results may help improve how doctors use imaging to guide treatment decisions for patients with ER-positive breast cancer.
Detailed description
Estrogen receptor (ER) status is a critical determinant of treatment strategy in breast cancer. While 18F-FDG PET/CT is widely used for metabolic assessment, it cannot directly visualize ER expression. 18F-FES is a radiolabeled estrogen analog that binds specifically to ER, enabling non-invasive visualization and quantification of ER expression in vivo. The combined use of 18F-FDG and 18F-FES PET/CT may provide complementary metabolic and receptor information for diagnosis, treatment planning, and therapeutic response assessment in ER-positive breast cancer.This study aims to evaluate the clinical utility of FES PET/CT in three domains: (1) diagnosis and characterization of ER-positive breast cancer lesions, (2) informing treatment planning by assessing ER expression heterogeneity, and (3) monitoring treatment response through quantitative changes in FES uptake.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected or new diagnosed or previously treated ER-positive breast cancer.
Key inclusion criteria (1 listed)
- (1) adult female patients aged ≥18 years; (2) ER-positive breast cancer confirmed by pathological biopsy; (3) underwent initial staging with18F-FES PET/CT scans.
Key exclusion criteria (1 listed)
- (1)patients with more than two primary tumors; (2) incomplete clinical or pathological records; and (3) inability to complete imaging studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance
Time frame: 1 year
Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FES PET/CT were calculated.
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 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hunan Cancer 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 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 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 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?
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?
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?
Diagnostic Performance (time frame: 1 year). 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 Oct 2026.