Using a new PET tracer to detect HER2-positive cancer in patients
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
This study is testing a new imaging tool to see if it can help find HER2-positive breast or gastric cancer more accurately in patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | chemotherapy, radiation, trastuzumab |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05955833 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a novel PET imaging tracer, 89Zr-DFO*-trastuzumab, in patients with HER2-positive breast or gastric cancer. Participants will receive an injection of the tracer and undergo three PET scans over a week to assess the tracer's ability to accurately identify tumor lesions. The study focuses on improving the detection of HER2-positive tumors, which is crucial for determining the effectiveness of HER2-targeted therapies. Blood samples will also be collected to support the research findings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with HER2-positive metastatic breast or gastric cancer who are starting new systemic treatment.
Not a fit: Patients with HER2-negative tumors or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to identify patients who will benefit from HER2-directed therapies, leading to more personalized treatment options.
How similar studies have performed: Previous studies using similar PET imaging approaches have shown promise, but this specific tracer is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amsterdam, Noord-Holland
- AmsterdamUMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: C.W. Menke-van der Houven van Oordt, MD, PhD — AmsterdamUMC
- Study coordinator: Jelijn Knip, MD
- Email: j.knip1@amsterdamumc.nl
- Phone: +31 6 21 45 55 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.