FES-PET/CT: Study of a new tracer for detection of ER protein in the cell nucleus in breast cancer

Phase 1

• Conditions: Breast cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002665-35-DK
• Lead Sponsor: Mikkel Holm Vendelbo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-12
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

- Patients with known disseminated breast cancer
- Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate foci visualised on CT
- Diagnostic CT performed in connection to clinical control
- Treatment with aromatase inhibitor and any additional treatments, or treatment with chemotherapy
- Postmenopausal status
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES PET/CT
- ER- metastases
- Life expectancy less than three months
- Claustrofobia
- Pain which make it impossible to lie still in the scanner for 90 minutes

Study & Design

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