NCT02095210

HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Dorte Nielsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A \[18F\]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product \[68Ga\]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.

Detailed description

see above

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
OTHER	Radiolabeled [68Ga]ABY-025	Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-08-13
• Completion: 2014-08-13
• First posted: 2014-03-24
• Last updated: 2020-10-05

Locations

1 site across 1 country: Denmark