Clinical trial · Interventional
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation for Prognosis Prediction and Response Evaluation of Hormone Therapy in Primary and Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The propose of this prospective study focuses on the role of \[18F\]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of \[18F\]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. \[18F\]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The \[18F\]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the \[18F\]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FES PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FES PET
- description
- PET/CT
- interventionNames
- Drug: 18F-FES PET
Primary outcomes (1)
- measure
- PET imaging
- timeFrame
- in 3 days
- description
- Visual interpretation will be performed first by two independent readers to record if there is any abnormal 18F-FES accumulation. The presence, number, size, character, and location of suspected lesions will be filed for each patient in this study. The final results will be validated by tissue proof, correlation with other imaging, or follow-up results. Semi-quantitative analysis will be performed for each lesion suspected during visual interpretation. Standardized uptake values (SUV) will be obtained by placing regions of interest (ROIs) around the lesions that are identified on visual analysis. The maximum SUV (SUVmax) will be recorded. Volumetric parameters will be performed by placing volume of interests (VOIs) around the suspected lesions. VOIs will be generated using defined fix SUV thresholds or algorithm-generated isocontours. Manual adjustment of VOIs is allowed when non-tumoral tissue is incorrectly included by automatic method.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients more than twenty years old * Patients with breast cancer proven by pathology or cytology * ER status evaluated by immunohistochemical (IHC) staining; Her2 status evaluated by IHC or in-situ hybridization (ISH) * Patients will receive hormone therapy as adjuvant therapy or treatment of metastatic disease * Patients with ESR1 gene analysis * Life expectancy \>3 months. * ECOG performance status 0 to 2 * Hematologic Function： 1. Neutrophil count ≥1.5×109/L 2. Platelet count ≥100×109/L 3. Hemoglobin ≥9.0 g/dL * Liver Function： 1. Total bilirubin level ≤ 1.5 mg/dL 2. Aspartate transaminase (AST) ≤ 77.5 U/L 3. alanine transaminase (ALT) ≤ 102.5 U/L 4. (1) Albumin \> 25 g/dL * Renal Function：Creatinine ≤ 2.0 mg/dL Exclusion Criteria: * Patients with known secondary malignancy other than breast cancer * Patients not suitable for hormone therapy after clinical assessment * Patients who received neoadjuvant chemotherapy, radiation or hormone therapy before the operation of newly diagnosed breast cancer * Patients treated with oral or intravenous cytotoxic agent(s) during the same period of hormone therapy * Pregnant or planning pregnant woman * Unclear consciousness * Allergy to drug * Cannot accept 18F-FES PET * Breastfeeding * There are other tumors * By doctor evaluation to unsuitable
References
Publications (0)
Data not yet available