Actively Recruiting
HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer
Led by Imperial College London · Updated on 2024-08-26
24
Participants Needed
1
Research Sites
407 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
M
Medical Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with breast cancer and known HER2 status (8 positive and 8 negative)
- Signed informed consent before joining the study
- Target lesion size of at least 15 mm that has not been irradiated
- Female patients aged 18 years or older
- Locally advanced or metastatic breast cancer confirmed by biopsy within the last 12 months showing HER2 status by IHC, SISH, or FISH
- ECOG performance status between 0 and 2
- Negative urine pregnancy test within 2 hours before imaging agent injection for women of childbearing age and agreement to use contraception for 3 weeks after injection
- Expected life span longer than 3 months
- Adequate organ function including hemoglobin ≥ 10 g/L, WBC ≥ 3.0 x 10^9/L, platelets ≥ 80 x 10^9/L, serum creatinine ≤ 1.4 mg/dL, liver enzymes ≤ 2 times upper limit of normal, and bilirubin ≤ 2 times upper limit or 3.0 mg/dL if Gilbert's syndrome
- Patients must have had FDG-PET staging within 42 days before study entry and any additional imaging as per standard care
You will not qualify if you...
- Pregnant or breastfeeding women
- History of serious heart diseases such as myocardial infarction, arrhythmias requiring treatment, symptomatic valve disease, cardiomyopathy, or pericarditis
- Any significant medical condition or lab result that makes participation unsafe according to the investigator
- Severe claustrophobia or inability to lie flat or fit into the scanner (weight limit 350 lbs / 160 kg)
- Use of any other investigational drug within 14 days before enrollment or concurrent use
- Classified as radiation workers
- Taking therapeutic doses of anticoagulants or having raised prothrombin time
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0NN
Actively Recruiting
Research Team
H
HERPET Trial Coordinator
CONTACT
G
Gosala Gopalakrishnan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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