FES (16a-[18F]-fluoro-17ß-estradiol)-PET: Towards a new standard to stage clinical stage II/III and recurrent, estrogen receptor positive (ER+) breast cancer? Pilot study to compare [18F]FES-PET and [18F]FDG-PET.

Phase 1

• Conditions: Breast cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002013-35-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

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 (<6
weeks) for current breast cancer and require staging because of unexpected stage III disease)
- [18F]FDG PET/CT imaging should be performed for staging according to standard of care (in case [18F]FDG PET/CT imaging has already been performed, patients can be included =21 days after this scan)
- Estimated glomerular filtration rate (eGFR) =30 ml/min
- Written and signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified