- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955833
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study (HER Image)
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%).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jelijn Knip, MD
- Phone Number: +31 6 21 45 55 45
- Email: j.knip1@amsterdamumc.nl
Study Contact Backup
- Name: Hylke Sebus, MD
- Phone Number: +31 6 25 71 60 36
- Email: h.j.sebus@amsterdamumc.nl
Study Locations
-
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1081 HV
- Recruiting
- AmsterdamUMC
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Contact:
- Jelijn Knip, MD
- Phone Number: +31 6 21 45 55 45
- Email: j.knip1@amsterdamumc.nl
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Contact:
- Hylke Sebus, MD
- Phone Number: +31 6 25 71 60 36
- Email: h.j.sebus@amsterdamumc.nl
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Principal Investigator:
- C.W. Menke-van der Houven van Oordt, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 89Zr-DFO*-trastuzumab PET
Patients undergoing the 89Zr-DFO*-trastuzumab PET-scans
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool.
Time Frame: SUVmean on day 4 post injection.
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SUVmean on day 4 post injection.
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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.
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SUVmean on day 4 post injection.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor uptake: 89Zr-DFO*-trastuzumab uptake (SUV, %ID/kg) in tumor lesions
Time Frame: SUV on day 4 post injection.
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SUV on day 4 post injection.
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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.
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SUV on day 4 post injection.
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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).
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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).
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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).
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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).
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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).
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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).
|
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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).
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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).
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Image-derived PK for 89Zr-DFO*-trastuzumab (µg/mL)
Time Frame: Day 1, 2 and 4 post injection (at each scan)
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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.
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Day 1, 2 and 4 post injection (at each scan)
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Literature-derived PK for unlabelled trastuzumab (Cmax in µg/mL)
Time Frame: Day of injection till 7 days post injection.
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Day of injection till 7 days post injection.
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Literature-derived PK for unlabelled trastuzumab (AUC in µg/mL × day)
Time Frame: Day of injection till 7 days post injection.
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Day of injection till 7 days post injection.
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Visual PET imaging analysis of tumor uptake of 89Zr-DFO*-trastuzumab and 89Zr-trastuzumab
Time Frame: Day 1, 2 and 4 post injection.
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Day 1, 2 and 4 post injection.
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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.
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Day 1, 2 and 4 post injection.
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Tumor-to-image derived blood uptake ratio of 89Zr-trastuzumab
Time Frame: Day 1, 2 and 4 post injection.
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Day 1, 2 and 4 post injection.
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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.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: C.W. Menke-van der Houven van Oordt, MD, PhD, AmsterdamUMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL82608.018.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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