Breast CancerEarly Phase 1NCT03321045
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
A Early Phase 1 study testing [89Zr]-Df-Trastuzumab and PET/MRI Imaging in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with… 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?
- [89Zr]-Df-Trastuzumab and PET/MRI Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2017to Oct 2028
- Phase
- Early Phase 1
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
- Be at least 18 years of age.
- Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number >= 6 OR dual probe ISH with both average HER2 copy number >= 4 AND HER2 to CEP17 ratio >=2
- Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
- Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans
Who cannot join
- Inability to provide informed consent
- Pregnancy
- Inability to lie still for the imaging study
- Weight over 350 lbs., due to the scanner bore size
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Kirklin Clinic
Birmingham, Alabama, 35249
About this study
Official title: PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.
- Conditions
- Breast Cancer
- Being tested
- [89Zr]-Df-Trastuzumab, PET/MRI Imaging
- Keywords
- 89Zr-Trastuzumab, HER2 Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]-Df-TrastuzumabDrug
[89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 mCi at the time of injection. The amount of injected drug is 5 mg of Trastuzumab.
PET/MRI ImagingDiagnostic test
5-6 days post injection the patients will undergo PET/MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]-Df-Trastuzumab | Experimental | [89Zr]-Df-Trastuzumab [89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging. Receives: Drug: [89Zr]-Df-Trastuzumab; Diagnostic Test: PET/MRI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with [89Zr]-Df-Trastuzumab in patients with newly diagnosed breast cancer.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start21 Nov 2017
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne E. Lapi, PhD, University of Alabama at Birmingham
- Investigators
- Suzanne E Lapi, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321045
- Sponsor's protocol ID
- IRB-170220004
- Other IDs
- UAB
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2017
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mansur A, McConathy JE, Stringer-Reasor E, Rocque G, Khoury K, Eltoum N, Nikpanah M, Bartels J, Wright B, Jahan N, Jeffers D, Lapi SE, Sorace AG. Quantitative [89Zr]Zr-Trastuzumab PET and Diffusion- Weighted MRI for Characterization of Metastatic HER2-Positive Breast Cancer with PET/MRI. J Nucl Med. 2025 Jul 1;66(7):1018-1026. doi: 10.2967/jnumed.124.268931.
PubMed 40473459