Breast CancerNCT03827317
HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer
A study testing [18F]GE-226 in people with Breast Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- [18F]GE-226
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0NN
Gosala Gopalakrishnan, PhD, 0207 59 42804, g.gopalakrishnan@imperial.ac.uk
Laura M Kenny, MBBS
About this study
Official title: HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography
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.
Read the detailed description
Objectives
Primary:
- To determine the uptake in tumour lesions and normal tissue of [18F]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake)
- To determine the optimal imaging time point for [18F]GE-226
Secondary:
- To determine the safety and toxicity of [18F]GE-226 PET in humans
- To determine if [18F]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours
- To determine the metabolism of [18F]GE-226 in human subjects
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:
- Safety and toxicity of [18F]GE-226 measured by adverse events from administration of [18F]GE-226 injection throughout the study period, and clinically significant changes from baseline measurements in serum biochemistry, haematology, coagulation, immunology, urinalysis, vital signs, ECG, injection site and physical examination findings.
- The association between [18F]GE-226 tumour uptake and standard HER2 pathological testing (HER2 amplified and HER2 non-amplified breast tumours)
- Proportion of metabolised [18F]GE-226 at scheduled time-points compared to baseline
- Normal tissue uptake of [18F]GE-226 will be quantified in the appropriate regions depending on the field of view.
Exploratory:
- To perform preliminary biodistribution analysis, to compare [18F]GE- 226 uptake to [18F]FDG uptake in tumour lesion
- Conditions
- Breast Cancer
- Being tested
- [18F]GE-226
- Keywords
- HER2, imaging, PET, positron emission tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]GE-226Radiation
[18F]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab. The active molecule is a 61 amino acid peptide that is modified site-specifically with one fluorobenzaldehyde molecule at the C-terminal.
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive metastatic breast cancer | Other | 8 HER2 positive patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours. Receives: Radiation: [18F]GE-226 |
| HER2 negative metastatic breast cancer | Other | 8 HER2 negative patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours. Receives: Radiation: [18F]GE-226 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters
Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using SUV and AUC.
Measured: 24 months
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using fully quantitative parameters
Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using Ki in the case or irreversible uptake, and binding potential in the case of reversible uptake.
Measured: 24 months
Secondary outcomes (6)
Adverse events of [18F]GE-226 injection
Safety of [18F]GE-226 measured by adverse events from administration of [18F]GE-226 injection throughout the study period.
Measured: 0 hour, 48 hours
Serum biochemistry change from baseline measurement
Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in serum biochemistry finding.
Measured: 0 hour, 48 hours
Haematology change from baseline measurement
Safety of [18F]GE-226 injection measured by haematology change from baseline measurements.
Measured: 0 hour, 48 hours
Immunology change from baseline measurement
Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in immunology
Measured: 0 hour, 48 hours
Urine change from baseline measurement
Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in urine
Measured: 0 hour, 48 hours
EEG change from baseline measurement
Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in ECG
Measured: 0 hour, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start8 Mar 2019
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised cohort
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Laura M Kenny, MD FRCP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827317
- Sponsor's protocol ID
- 2015-004027-31
- Other IDs
- 2015
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2019
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT03827317
- Acronym / sponsor ID
- 2015-004027-31
- Conditions
- Breast Cancer
- Keywords
- HER2, imaging, PET, positron emission tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, University of Cambridge
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives
Primary:
- To determine the uptake in tumour lesions and normal tissue of [18F]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake)
- To determine the optimal imaging time point for [18F]GE-226
Secondary:
- To determine the safety and toxicity of [18F]GE-226 PET in humans
- To determine if [18F]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours
- To determine the metabolism of [18F]GE-226 in human subjects
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:
- Safety and toxicity of [18F]GE-226 measured by adverse events from administration of [18F]GE-226 injection throughout the study period, and clinically significant changes from baseline measurements in serum biochemistry, haematology, coagulation, immunology, urinalysis, vital signs, ECG, injection site and physical examination findings.
- The association between [18F]GE-226 tumour uptake and standard HER2 pathological testing (HER2 amplified and HER2 non-amplified breast tumours)
- Proportion of metabolised [18F]GE-226 at scheduled time-points compared to baseline
- Normal tissue uptake of [18F]GE-226 will be quantified in the appropriate regions depending on the field of view.
Exploratory:
- To perform preliminary biodistribution analysis, to compare [18F]GE- 226 uptake to [18F]FDG uptake in tumour lesion
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised cohort
| Arm | Type | Receives |
|---|---|---|
| HER2 positive metastatic breast cancer | Other | Radiation: [18F]GE-2268 HER2 positive patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours. |
| HER2 negative metastatic breast cancer | Other | Radiation: [18F]GE-2268 HER2 negative patients (determined using the most recent biopsy) will be recruited. Dynamic [18F]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]GE-226[18F]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab. The active molecule is a 61 amino acid peptide that is modified site-specifically with one fluorobenzaldehyde molecule at the C-terminal. | Radiation | HER2 negative metastatic breast cancer, HER2 positive metastatic breast cancer |
Primary outcome
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters
Time frame: 24 months
Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using SUV and AUC.
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using fully quantitative parameters
Time frame: 24 months
Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using Ki in the case or irreversible uptake, and binding potential in the case of reversible uptake.
6 secondary outcomes
Adverse events of [18F]GE-226 injection
Time frame: 0 hour, 48 hours
Serum biochemistry change from baseline measurement
Time frame: 0 hour, 48 hours
Haematology change from baseline measurement
Time frame: 0 hour, 48 hours
Immunology change from baseline measurement
Time frame: 0 hour, 48 hours
Urine change from baseline measurement
Time frame: 0 hour, 48 hours
EEG change from baseline measurement
Time frame: 0 hour, 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura M Kenny, MD FRCP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]GE-226 in people with Breast Cancer, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HERPET Trial Coordinator (0207 59 42804, herpet@imperial.ac.uk; g.gopalakrishnan@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.