AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
  • TongjiHospital

    Wuhan, Hubei, 430030

    xiaohua zhu, Dr.

    Recruiting

Other trials in China

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 .

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.

  1. 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.

  1. First posted15 Sep 2022
  2. Study start31 Dec 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in