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This mechanistic study will be the first study to assess the efficacy of [18F]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of [18F]GE-226 and the optimum time-point for performing static scans in this patient population.
Full description
Objectives
Primary:
Secondary:
Exploratory:
• To explore circulating biomarkers that may be related to [18F]GE-226 uptake and to investigate if treatment modulates [18F]GE-226
Endpoints
Secondary:
Exploratory:
• To perform preliminary biodistribution analysis, to compare [18F]GE- 226 uptake to [18F]FDG uptake in tumour lesion
Enrollment
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Volunteers
Inclusion criteria
Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
Written informed consent prior to admission in the study.
Target lesion diameter of ≥15mm that has not been previously irradiated.
Female patients aged ≥ 18 years of age.
For all patients: histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the last 12 months confirming HER2 status by either immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In Situ Hybridization (FISH).
ECOG performance status 0-2
Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of [18F]GE-226
Life expectancy > 3 months
Adequate organ function as defined by
Patients must have been appropriately staged using FDG-PET within 42 days of study entry and additional imaging according to local standard of care
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Central trial contact
HERPET Trial Coordinator; Gosala Gopalakrishnan, PhD
Data sourced from clinicaltrials.gov
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