Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer

Breast Cancer Clinical Trial

— FEStastic  

Official title:

Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088785
• Other study ID #: NL76658.029.21
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Catherina W Menke-van der Houven van Oordt, MD PhD
• Phone: +31 (0)20 4444 773
• Email: dm-onco[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

16a-18F-fluoro-17b-estradiol ([18F]FES) is radioactive labeled estradiol, developed for in vivo visualization of the estrogen receptor (ER) using positron emission tomography (PET). To date, [18F]FES PET has been mainly explored as a diagnostic imaging tool to assess ER expression, thereby identifying locations of disease and their potential sensitivity to endocrine therapy, respectively. The primary aim of this project is to extend the application of [18F]FES PET as a baseline diagnostic imaging biomarker for ER expression to use it as an (early) treatment response marker. However, for such an application, visual assessment alone may not be sufficient and a more rigorous quantitative image analysis is needed. Therefore, in this project we shall first derive the optimal pharmacokinetic model for full quantitative analysis of [18F]FES uptake and, subsequently, we shall assess the validity of simplified, clinically feasible, quantitative parameters of [18F]FES uptake in 5 patients with metastatic estrogen receptor positive (ER+) breast cancer (part A). In addition, the repeatability of these simplified parameters will then be investigated in another 10 patients (part B).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven metastatic ER+ (>10% positive stained cells using immunohistochemistry) breast cancer on the latest biopsy

• Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following:

1. age =60 years

2. age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)

3. patient age <60 years using LH-RH agonists should continue LH- RH-agonists until after the PET procedures

4. previous bilateral oophorectomy or medically confirmed ovarian failure

• [18F]FDG PET, CT and/or a bone scan should be performed as part of routine clinical staging (=4 weeks prior to screening)

• Patients should have metastases in the scanning field of view, all located outside of the liver

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2

• Estimated glomerular filtration rate (eGFR) =30 ml/min

• Written and signed informed consent

Exclusion Criteria:

• History with another cancer within the last 5 years, except cancer treated with curative intent and no evidence of disease as judged by the treating physician

• Use of selective estrogen receptor modulators (SERMs) or downregulators (SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (=5 weeks prior to screening) or investigational drug therapy

• Pregnancy or lactating women

• Any medical, psychological or social condition that may interfere with the subject's safety and participation in the study, will lead to exclusion from this study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• FES
[18F]FES PET imaging.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC - location VUmc	Amsterdam	North-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SUV and TBR values	Repeatability of standardized uptake values and tumor-to-blood ratios will be assessed.	1 year.
Primary	FES uptake in lesions: Ki (net influx rate) or VT (volume of distribution) values	FES uptake in lesions will be expressed as Ki or VT values	1 year
Secondary	SUV and TBR values	Quantification of FES uptake in lesions will be assessed by determining standardized uptake values and tumor-to-blood ratios.	1 year.