Breast cancer.
Conditions
Interventions
Product Name: 16a-[18F]fluoro-17ß-estradiol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 16ALFA-18F-FLUORO-17BETA-ESTRADIOL
Other descriptive name: 16ALFA-18F-FLUORO-17BETA-ESTRADI
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical stage II/III or LRR breast cancer (all histological types) with ER+ and low grade according to Bloom Richardson criteria (grade 1-2) - Females aged 18 years or older at screening - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 - Candidates for treatment with curative intent (patients are also allowed for inclusion in the current study if they have undergone recent surgery (=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - History with another cancer within the last 5 years, except non-melanoma skin cancer - Undergoing treatment for current breast cancer such as (neo)adjuvant chemotherapy, hormonal therapy (only in case of Tamoxifen), radiotherapy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether [18F]FES PET/CT improves staging for women with clinical stage II/III or LRR, grade 1-2, ER+ breast cancer as compared to standard [18F]FDG PET/CT. ;Secondary Objective: 1) To compare [18F]FDG- and [18F]FES PET imaging outcomes to clinicopathological parameters - Standard parameters: size, location of lesion, histological subtype, grade, ER/PR/HER2 expression levels, Ki67%/mitotic index - Experimental parameters: intensity of ER staining, tumor cell and microvessel density, infiltration of lymphocytes, amount of necrosis and stroma, expression of glucose transporter-1 (GLUT1) of the primary tumor, lymph node and distant metastases 2) To obtain evidence for initiating a larger clinical trial to define the added value of [18F]FES PET/CT for staging patients with ER+, clinically LABC and/or LRR breast cancer. ;Primary end point(s): 1) Percentage of patients with a correctly changed treatment plan according to information obtained with [18F]FES PET/CT compared to [18F]FDG PET/CT at staging. 2) Percentage of metastatic lesions detected with [18F]FES PET/CT compared to [18F]FDG PET/CT at staging. 3) Percentage of missed metastases with [18F]FES PET/CT compared to [18F]FDG PET/CT (at staging and developed during follow-up). 4) Percentage of correct treatment plans as well as diagnostic confidence after 6 months of follow-up as determined by the adjudication committee based on the added information obtained with [18F]FES PET/CT compared to [18F]FDG PET/CT. ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated during the follow-up. The standard follow-up will take place every 3 months for a time period of 24 months after diagnosis to detect potentially missed metastases. At 6 months of follow-up, the treatment plan will be evaluated by an independent committee (surgeon, medical oncologist and nuclear physician/radiologist). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The relationship between the level of [18F]FES/[18F]FDG uptake in the primary tumor, lymph node and distant metastases and standard (size, location of lesion, histological subtype, grade, ER/PR/HER2 expression levels, Ki67%/mitotic index)/experimental clinicopathological parameters (intensity of ER staining, tumor cell and microvessel density, infiltration of lymphocytes, amount of necrosis and stroma, expression of glucose transporter-1 (GLUT1) of the primary tumor, lymph node and distant metastases). 2) Cut off value for [18F]FDG SUV (max and peak) below which [18F]FES PET/CT adds information for staging. 3) Cut off value for grade and ER expression level below which or above which, respectively, [18F]FES PET/CT adds information for staging. ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated during the follow-up. The standard follow-up will take place every 3 months for a time period of 24 months after diagnosis to detect potentially missed metastases. At 6 months of follow-up, the treatment plan will be evaluated by an independent committee (surgeon, medical oncologist and nuclear physician/radiologist). | — |
Countries
Netherlands
Contacts
Public ContactTrial Office
VU University Medical Center
Outcome results
None listed