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

NCT05088785 | Recruiting

• 1 other identifier: NL76658.029.21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SUV and TBR values

  1 year.

Other Outcomes (1)

• SUV and TBR values

  1 year.

Study Arms (2)

Part A: dynamic FES PET imaging

EXPERIMENTAL

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

Drug: FES

Part B: whole body static FES PET imaging

EXPERIMENTAL

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

Drug: FES

Interventions

FES DRUG

\[18F\]FES PET imaging.

Part A: dynamic FES PET imaging; Part B: whole body static FES PET imaging

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC - location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Catherina W Menke-van der Houven van Oordt, MD PhD

CONTACT

+31 (0)20 4444 773; dm-onco@amsterdamumc.nl

Data-management Medical Oncology

CONTACT

+31 (0)20 4444 773; dm-onco@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 22, 2021
• Study Start: October 11, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)