HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03827317

Run by

Imperial College London

People needed

24

Starts

2019-03-08

Expected to finish

2026-12-31

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Hb≥10g/L
• WBC≥3.0 x 109/L
• PLT≥80 x 109/L
• Serum creatinine ≤1.4mg/dl
• SGOT and SGPT ≤2 x ULN
• Total bilirubin ≤ 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome
• Patients must have been appropriately staged using FDG-PET within 42 days of study entry and additional imaging according to local standard of care

You may not qualify if…

• Pregnant or lactating women.
• History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
• Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.
• Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)).
• Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
• Patients classified as radiation workers
• Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time

Where it is running

• Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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