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

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Recruiting

CT.gov ID

NCT05088785

Collaborator

(none)

Enrollment

Location

Arms

6.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: FES	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Apr 22, 2022

Anticipated Study Completion Date :

Apr 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: dynamic FES PET imaging All patients included in part A will receive a dynamic FES PET/CT scan.	Drug: FES [18F]FES PET imaging.
Experimental: Part B: whole body static FES PET imaging All patients included in part B will receive a whole body static FES PET/CT scan twice within 1 week.	Drug: FES [18F]FES PET imaging.

Arm

Intervention/Treatment

Experimental: Part A: dynamic FES PET imaging

All patients included in part A will receive a dynamic FES PET/CT scan.

Drug: FES

[18F]FES PET imaging.

Experimental: Part B: whole body static FES PET imaging

All patients included in part B will receive a whole body static FES PET/CT scan twice within 1 week.

Drug: FES

[18F]FES PET imaging.

Outcome Measures

Primary Outcome Measures

FES uptake in lesions: Ki (net influx rate) or VT (volume of distribution) values [1 year]
FES uptake in lesions will be expressed as Ki or VT values

Secondary Outcome Measures

SUV and TBR values [1 year.]
Quantification of FES uptake in lesions will be assessed by determining standardized uptake values and tumor-to-blood ratios.

Other Outcome Measures

SUV and TBR values [1 year.]
Repeatability of standardized uptake values and tumor-to-blood ratios will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

age ≥60 years
age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
patient age <60 years using LH-RH agonists should continue LH- RH-agonists until after the PET procedures
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC - location VUmc	Amsterdam	North-Holland	Netherlands	1081 HV

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

C. Menke- van der Houven van Oordt, Principal investigator, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT05088785

Other Study ID Numbers:

NL76658.029.21

First Posted:

Oct 22, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 2, 2021