Breast CancerHER ImageNCT05955833
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
A study testing 89Zr-DFO*-trastuzumab PET scan in people with Breast Cancer and Metastatic Breast Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- 89Zr-DFO*-trastuzumab PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HER2+ breast cancer with metastatic disease starting (new) systemic treatment or
- HER2+ metastatic gastric cancer starting (new) systemic treatment.
- A recent (< 8 weeks of start of study) biopsy confirming HER2+.
- Able to undergo PET imaging procedures.
- At least one lesion of at least 1.5 cm amenable for PET imaging
- Age >18 years of age, willing and able to comply with the protocol as judged by the investigator.
Show all 17Show fewer
- Signed written informed consent.
- Have a World Health Organisation (WHO) performance status of 0-2.
- Life expectancy of > 3 months.
- Have measurable disease based on RECIST 1.1.
- Adequate organ and bone marrow function, as deemed acceptable by the treating physician
- Women aged <50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.
- Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago.
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP.
- Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP.
- Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
Who cannot join
- Contraindications for systemic treatment (as will be assigned by treating physician).
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures.
- Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies.
Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection.
The amount of radioactivity injected will be 37 MBq (± 10%).
Read the detailed description
Positron emission tomography (PET) imaging with 89Zr-labeled trastuzumab can potentially discriminate between human epidermal growth factor 2 (HER2) positive and HER2-negative lesions in cancer patients. The obvious advantage over tumor biopsies is that PET imaging provides an overview regarding the heterogeneity of HER2-positivity of all lesions in the patient noninvasively at any given time. The use of a tracer with high specificity and low background signal is critical for accurately identifying positive lesions in patients. Earlier studies in patients with HER2-positive (HER2+) breast cancer and gastric cancer using 89Zr-trastuzumab led to the identification of HER2-positive tumor lesions. However, also lesions were missed and false-positive lesions were seen. Previous work has shown that organs like liver and spleen have significant uptake of 89Zr-trastuzumab. In addition, HER2-directed therapy is most effective in HER2-positive tumors, which are defined as immunohistochemistry (IHC) HER2 expression 3+ or HER2 2+ with gene amplification. Tumors with IHC 0, 1+ or 2+ without amplification are considered HER2-negative. To be able to discriminate between these expression levels with PET imaging, an excellent signal to background ratio is required. Recently, an improved 89Zr-labeled trastuzumab tracer has been developed using a different chelator for 89Zr binding, DFO*, which further improves stability of the 89Zr-labeled trastuzumab tracer. 89Zr-DFO*-trastuzumab preclinically shows improved specificity in uptake of tumor lesions while non-tumor related uptake in bone, liver and spleen is reduced, potentially improving the discrimination of HER2-positive tumor lesions in patients. The investigators hypothesize that the improved 89Zr-DFO*-trastuzumab tracer will lead to a reduced background uptake and thus a better discrimination of HER2-positive tumor lesions.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer, Metastatic Gastric Cancer, HER2-positive Gastric Cancer
- Being tested
- 89Zr-DFO*-trastuzumab PET scan
- Keywords
- PET Imaging, HER2, DFO*, trastuzumab
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO*-trastuzumab PET scanDiagnostic test
Patients will be administered 37 MBq 89Zr-DFO*-trastuzumab and undergo 3 PET scans on the total body PET scanner at day 1, day 2 and day 4 post-injection (p.i.). The first 3 patients will undergo an additional PET 1-2 h p.i. for dosimetry purposes. Three scans are needed for PK modelling and day 4 p.i. is chosen because it is the same time point as in historical controls. Blood samples for (radioactive) PK analysis will be taken at 10 min, 30 min, 1 h and 2 h p.i., and at every PET scan.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-DFO*-trastuzumab PET | Experimental | Patients undergoing the 89Zr-DFO*-trastuzumab PET-scans Receives: Diagnostic Test: 89Zr-DFO*-trastuzumab PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool.
Measured: SUVmean on day 4 post injection.
89Zr-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.
Measured: SUVmean on day 4 post injection.
Secondary outcomes (13)
Tumor uptake: 89Zr-DFO*-trastuzumab uptake (SUV, %ID/kg) in tumor lesions
Measured: SUV on day 4 post injection.
Tumor uptake: 89Zr-trastuzumab uptake (SUV, %ID/kg) in tumor lesions in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.
Measured: SUV on day 4 post injection.
Whole blood pharmacokinetics (PK) of 89Zr-DFO*-trastuzumab (Maximum Plasma Concentration (Cmax) µg/mL)
Measured: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Whole blood PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)
Measured: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Plasma PK of 89Zr-DFO*-trastuzumab (Cmax in µg/mL)
Measured: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Plasma PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)
Measured: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Image-derived PK for 89Zr-DFO*-trastuzumab (µg/mL)
For each timepoint, volumes of interest (VOIs) will be delineated in the aorta ascendens, and the activity of the VOI will be calculated afterwards for each timepoint. This calculated activity (in Bq/mL) will then be recalculated to the actual amount of tracer (in µg/mL), which is the image-derived PK.
Measured: Day 1, 2 and 4 post injection (at each scan)
Literature-derived PK for unlabelled trastuzumab (Cmax in µg/mL)
Measured: Day of injection till 7 days post injection.
Literature-derived PK for unlabelled trastuzumab (AUC in µg/mL × day)
Measured: Day of injection till 7 days post injection.
Visual PET imaging analysis of tumor uptake of 89Zr-DFO*-trastuzumab and 89Zr-trastuzumab
Measured: Day 1, 2 and 4 post injection.
Tumor-to-blood ratio of 89Zr-DFO*-trastuzumab (whole blood and plasma as well as image derived)
Measured: Day 1, 2 and 4 post injection.
Tumor-to-image derived blood uptake ratio of 89Zr-trastuzumab
Measured: Day 1, 2 and 4 post injection.
HER2 expression measured by IHC on tumor biopsies
Measured: The biopsies are at most 8 weeks old at the day of injection, and will be compared with the data of the scans from day 1, 2 and 4 post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start26 Jun 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
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 Amsterdam UMC, location VUmcThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, C. Menke- van der Houven van Oordt, Amsterdam UMC, location VUmc
- Investigators
- C.W. Menke-van der Houven van Oordt, MD, PhD, Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955833
- Sponsor's protocol ID
- NL82608.018.22
- Acronym
- HER Image
- Status last verified
- Oct 2025
- First submitted
- 30 Jun 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
- ClinicalTrials.gov ID
- NCT05955833
- Acronym / sponsor ID
- HER Image / NL82608.018.22
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer, Metastatic Gastric Cancer, HER2-positive Gastric Cancer
- Keywords
- PET Imaging, HER2, DFO*, trastuzumab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Jul 2023 (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.
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies.
Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection.
The amount of radioactivity injected will be 37 MBq (± 10%).
Detailed description
Positron emission tomography (PET) imaging with 89Zr-labeled trastuzumab can potentially discriminate between human epidermal growth factor 2 (HER2) positive and HER2-negative lesions in cancer patients. The obvious advantage over tumor biopsies is that PET imaging provides an overview regarding the heterogeneity of HER2-positivity of all lesions in the patient noninvasively at any given time. The use of a tracer with high specificity and low background signal is critical for accurately identifying positive lesions in patients. Earlier studies in patients with HER2-positive (HER2+) breast cancer and gastric cancer using 89Zr-trastuzumab led to the identification of HER2-positive tumor lesions. However, also lesions were missed and false-positive lesions were seen. Previous work has shown that organs like liver and spleen have significant uptake of 89Zr-trastuzumab. In addition, HER2-directed therapy is most effective in HER2-positive tumors, which are defined as immunohistochemistry (IHC) HER2 expression 3+ or HER2 2+ with gene amplification. Tumors with IHC 0, 1+ or 2+ without amplification are considered HER2-negative. To be able to discriminate between these expression levels with PET imaging, an excellent signal to background ratio is required. Recently, an improved 89Zr-labeled trastuzumab tracer has been developed using a different chelator for 89Zr binding, DFO*, which further improves stability of the 89Zr-labeled trastuzumab tracer. 89Zr-DFO*-trastuzumab preclinically shows improved specificity in uptake of tumor lesions while non-tumor related uptake in bone, liver and spleen is reduced, potentially improving the discrimination of HER2-positive tumor lesions in patients. The investigators hypothesize that the improved 89Zr-DFO*-trastuzumab tracer will lead to a reduced background uptake and thus a better discrimination of HER2-positive tumor lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-DFO*-trastuzumab PET | Experimental | Diagnostic Test: 89Zr-DFO*-trastuzumab PET scanPatients undergoing the 89Zr-DFO*-trastuzumab PET-scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- HER2+ breast cancer with metastatic disease starting (new) systemic treatment or
- HER2+ metastatic gastric cancer starting (new) systemic treatment.
- A recent (< 8 weeks of start of study) biopsy confirming HER2+.
- Able to undergo PET imaging procedures.
- At least one lesion of at least 1.5 cm amenable for PET imaging
Key exclusion criteria (5 listed)
- Contraindications for systemic treatment (as will be assigned by treating physician).
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures.
- Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
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 |
|---|---|---|
| 89Zr-DFO*-trastuzumab PET scanPatients will be administered 37 MBq 89Zr-DFO*-trastuzumab and undergo 3 PET scans on the total body PET scanner at day 1, day 2 and day 4 post-injection (p.i.). The first 3 patients will undergo an additional PET 1-2 h p.i. for dosimetry purposes. Three scans are needed for PK modelling and day 4 p.i. is chosen because it is the same time point as in historical controls. Blood samples for (radioactive) PK analysis will be taken at 10 min, 30 min, 1 h and 2 h p.i., and at every PET scan. | Diagnostic test | 89Zr-DFO*-trastuzumab PET |
Primary outcome
89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool.
Time frame: SUVmean on day 4 post injection.
89Zr-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.
Time frame: SUVmean on day 4 post injection.
13 secondary outcomes
Tumor uptake: 89Zr-DFO*-trastuzumab uptake (SUV, %ID/kg) in tumor lesions
Time frame: SUV on day 4 post injection.
Tumor uptake: 89Zr-trastuzumab uptake (SUV, %ID/kg) in tumor lesions in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging.
Time frame: SUV on day 4 post injection.
Whole blood pharmacokinetics (PK) of 89Zr-DFO*-trastuzumab (Maximum Plasma Concentration (Cmax) µg/mL)
Time frame: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Whole blood PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)
Time frame: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Plasma PK of 89Zr-DFO*-trastuzumab (Cmax in µg/mL)
Time frame: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Plasma PK of 89Zr-DFO*-trastuzumab (AUC µg/mL × h)
Time frame: PK samples are taken at 10, 30, 60 and 120 min post injection, and at 1, 2 and 4 days post injection (at the day of each scan).
Image-derived PK for 89Zr-DFO*-trastuzumab (µg/mL)
Time frame: Day 1, 2 and 4 post injection (at each scan)
Literature-derived PK for unlabelled trastuzumab (Cmax in µg/mL)
Time frame: Day of injection till 7 days post injection.
Literature-derived PK for unlabelled trastuzumab (AUC in µg/mL × day)
Time frame: Day of injection till 7 days post injection.
Visual PET imaging analysis of tumor uptake of 89Zr-DFO*-trastuzumab and 89Zr-trastuzumab
Time frame: Day 1, 2 and 4 post injection.
Tumor-to-blood ratio of 89Zr-DFO*-trastuzumab (whole blood and plasma as well as image derived)
Time frame: Day 1, 2 and 4 post injection.
Tumor-to-image derived blood uptake ratio of 89Zr-trastuzumab
Time frame: Day 1, 2 and 4 post injection.
HER2 expression measured by IHC on tumor biopsies
Time frame: The biopsies are at most 8 weeks old at the day of injection, and will be compared with the data of the scans from day 1, 2 and 4 post injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
C.W. Menke-van der Houven van Oordt, MD, PhD principal investigator
AmsterdamUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-DFO*-trastuzumab PET scan in people with Breast Cancer and Metastatic Breast Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 17 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool. (time frame: SUVmean on day 4 post injection.). 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 27 May 2026.