search
Back to results

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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FES
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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:

    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

Sites / Locations

  • Amsterdam UMC - location VUmcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: dynamic FES PET imaging

Part B: whole body static FES PET imaging

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2021
Last Updated
October 13, 2022
Sponsor
Amsterdam UMC, location VUmc
search

1. Study Identification

Unique Protocol Identification Number
NCT05088785
Brief Title
Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer
Acronym
FEStastic
Official Title
Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: dynamic FES PET imaging
Arm Type
Experimental
Arm Description
All patients included in part A will receive a dynamic FES PET/CT scan.
Arm Title
Part B: whole body static FES PET imaging
Arm Type
Experimental
Arm Description
All patients included in part B will receive a whole body static FES PET/CT scan twice within 1 week.
Intervention Type
Drug
Intervention Name(s)
FES
Intervention Description
[18F]FES PET imaging.
Primary Outcome Measure Information:
Title
FES uptake in lesions: Ki (net influx rate) or VT (volume of distribution) values
Description
FES uptake in lesions will be expressed as Ki or VT values
Time Frame
1 year
Secondary Outcome Measure Information:
Title
SUV and TBR values
Description
Quantification of FES uptake in lesions will be assessed by determining standardized uptake values and tumor-to-blood ratios.
Time Frame
1 year.
Other Pre-specified Outcome Measures:
Title
SUV and TBR values
Description
Repeatability of standardized uptake values and tumor-to-blood ratios will be assessed.
Time Frame
1 year.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherina W Menke-van der Houven van Oordt, MD PhD
Phone
+31 (0)20 4444 773
Email
dm-onco@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Data-management Medical Oncology
Phone
+31 (0)20 4444 773
Email
dm-onco@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC - location VUmc
City
Amsterdam
State/Province
North-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramsha Iqbal, MD
Email
r.iqbal@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Ramsha Iqbal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs