Breast CancerNCT05541367
Estrogen Receptor (ER) PET/CT Imaging in Breast Cancer
An observational study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
18F-Fluoroestradiol (18F-FES) is an estrogen receptor-targeting positron emission tomography tracer with high sensitivity and specificity for the detection of estrogen receptor(ER)-positive tumors . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Estrogen-receptor-negative Breast Cancer
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients should be more than 18 years old,and have been pathologically confirmed breast cancer.
Who may be able to join
- More than 18 years old
- Patients with pathologically confirmed breast cancer
- Sign the informed consent form
Who cannot join
- Pregnant women
- Severe underlying diseases that cannot cooperate with PET examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
TongjiHospital
Wuhan, Hubei, 430030
xiaohua zhu, Dr.
About this study
18F-Fluoroestradiol (18F-FES) is an estrogen receptor-targeting positron emission tomography tracer with high sensitivity and specificity for the detection of estrogen receptor(ER)-positive tumors . 18F-FES has been used as a predictive biomarker to demonstrate estrogen receptor heterogeneity , to evaluate the pharmacokinetics of estrogen receptor-targeted drugs , to measure residual estrogen receptors during endocrine therapy and to determine biologically optimal doses of novel estrogen receptor-targeted drugs .This study aimes to explore the efficacy of 18F-FES PET/CT in evaluating the expression levels of ER in primary and metastatic breast cancer patients.
Read the detailed description
Breast cancer is the most common cancer in women, and up to 70% of breast cancer patients are positive for hormone receptors. Most of them are estrogen receptor (ER) positive, and more than 95% of progesterone receptor (PR) positive tumors are also ER positive. The staging system most commonly used for BC is the American Joint Committee on Cancer TNM system, which is based on seven criteria - tumor extent (T), spread to nearby lymph nodes (N), spread (metastasis) to distant sites (M), cancer grade ( G), estrogen receptor (ER) status, progesterone receptor status (PR) and HER2/neu . Breast cancer is characterized by different pathological features, different responses to treatment, and significant differences in long-term survival among patients . In general, the molecular typing of breast cancer is mainly divided into four types: the first, luminalA type refers to ER, PR positive, HER2 negative, and endocrine therapy can be performed. The second, luminalB type means that ER, PR and HER2 are all positive, endocrine therapy, chemotherapy and targeted therapy can be used, and the therapeutic effect is relatively good. The third type, HER2 overexpression type is HER2 positive, ER and PR are both negative, this type is ineffective for endocrine therapy, and targeted therapy can be used. Fourth, ER, PR and HER2 are all negative , and the treatment effect is the worst. In general, the two subtypes of luminalA and B have higher long-term survival rates. Meanwhile,HER2 overexpression and triple-negative breast cancer have a poor prognosis.
The success of breast cancer treatment depends heavily on tumor estrogen receptor status, which is currently assessed by immunohistochemistry. While immunohistochemistry is well suited to detect primary breast tumors, metastatic foci are less accurate. Estrogen receptor expression changes over time, and inconsistent expression between primary and metastatic tumors has been observed in up to 40% of patients.Studies have shown the potential role of FES-PET/CT in assessing ER status, especially in patients with multiple tumors or that are difficult to biopsy.FES-PET/CT as an imaging technique targeting estrogen receptors may help predict patient response to endocrine therapy. Therefore, FES PET/CT imaging is of great significance for the selection of patients who benefit from endocrine therapy and those who are better through adjuvant chemotherapy .
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Estrogen-receptor-negative Breast Cancer
- Keywords
- Estrogen receptor, PET/CT, breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
SUVmax
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start31 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Tongji 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZHU XIAOHUA, DR, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541367
- Sponsor's protocol ID
- TJ-IRB20211128
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Receptor (ER) PET/CT Imaging in Breast Cancer
- ClinicalTrials.gov ID
- NCT05541367
- Acronym / sponsor ID
- TJ-IRB20211128
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Estrogen-receptor-negative Breast Cancer
- Keywords
- Estrogen receptor, PET/CT, breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 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 (18F-FES) is an estrogen receptor-targeting positron emission tomography tracer with high sensitivity and specificity for the detection of estrogen receptor(ER)-positive tumors . 18F-FES has been used as a predictive biomarker to demonstrate estrogen receptor heterogeneity , to evaluate the pharmacokinetics of estrogen receptor-targeted drugs , to measure residual estrogen receptors during endocrine therapy and to determine biologically optimal doses of novel estrogen receptor-targeted drugs .This study aimes to explore the efficacy of 18F-FES PET/CT in evaluating the expression levels of ER in primary and metastatic breast cancer patients.
Detailed description
Breast cancer is the most common cancer in women, and up to 70% of breast cancer patients are positive for hormone receptors. Most of them are estrogen receptor (ER) positive, and more than 95% of progesterone receptor (PR) positive tumors are also ER positive. The staging system most commonly used for BC is the American Joint Committee on Cancer TNM system, which is based on seven criteria - tumor extent (T), spread to nearby lymph nodes (N), spread (metastasis) to distant sites (M), cancer grade ( G), estrogen receptor (ER) status, progesterone receptor status (PR) and HER2/neu . Breast cancer is characterized by different pathological features, different responses to treatment, and significant differences in long-term survival among patients . In general, the molecular typing of breast cancer is mainly divided into four types: the first, luminalA type refers to ER, PR positive, HER2 negative, and endocrine therapy can be performed. The second, luminalB type means that ER, PR and HER2 are all positive, endocrine therapy, chemotherapy and targeted therapy can be used, and the therapeutic effect is relatively good. The third type, HER2 overexpression type is HER2 positive, ER and PR are both negative, this type is ineffective for endocrine therapy, and targeted therapy can be used. Fourth, ER, PR and HER2 are all negative , and the treatment effect is the worst. In general, the two subtypes of luminalA and B have higher long-term survival rates. Meanwhile,HER2 overexpression and triple-negative breast cancer have a poor prognosis.
The success of breast cancer treatment depends heavily on tumor estrogen receptor status, which is currently assessed by immunohistochemistry. While immunohistochemistry is well suited to detect primary breast tumors, metastatic foci are less accurate. Estrogen receptor expression changes over time, and inconsistent expression between primary and metastatic tumors has been observed in up to 40% of patients.Studies have shown the potential role of FES-PET/CT in assessing ER status, especially in patients with multiple tumors or that are difficult to biopsy.FES-PET/CT as an imaging technique targeting estrogen receptors may help predict patient response to endocrine therapy. Therefore, FES PET/CT imaging is of great significance for the selection of patients who benefit from endocrine therapy and those who are better through adjuvant chemotherapy .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients should be more than 18 years old,and have been pathologically confirmed breast cancer.
Key inclusion criteria (3 listed)
- More than 18 years old
- Patients with pathologically confirmed breast cancer
- Sign the informed consent form
Key exclusion criteria (2 listed)
- Pregnant women
- Severe underlying diseases that cannot cooperate with PET examination
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
SUVmax
Time frame: 5 years
SUVmax
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 15 Sep 2022.
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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.
ZHU XIAOHUA, DR principal investigator
Tongji Hospital
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 and TNBC - Triple-Negative Breast Cancer, run by Tongji 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 2 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 15 Sep 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?
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 ZHU XIAOHUA, DR (13971513770 ext. 18012908238, evazhu@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 5 years). 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 15 Sep 2022.