An Early Phase 1 interventional study of [89Zr]-Df-Trastuzumab and PET/MRI Imaging in Breast Cancer, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by University of Alabama at Birmingham · Early Phase 1, Interventional, and Diagnostic
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Among 46 studies in Breast Neoplasms by University of Alabama at Birmingham — 7 open to participants now, 11 under way, none of them phase 3. Breast Neoplasms · University of Alabama at Birmingham.
Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, this one is the 38th largest by planned enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2017, is one of 8 in phase 1, reaches primary completion later than 8 of the 10 other live ones, and was the 23rd registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →7 of the 46 studies in Breast Neoplasms by University of Alabama at Birmingham are open now, in 1 country. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+
University of Alabama at Birmingham · Sites in United States
Ages 18–90 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 60+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13
First in 2000; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 35 across the 42 interventional studies, 200 across the 3 observational. Of the 32 that completed or were terminated, 11 (34%) have results posted.
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University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
3 of the studies in Breast Neoplasms by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06924788University of Alabama at BirminghamVideo-Conferenced Stress Management and Relaxation Training (VSMART) For Alabama Breast Cancer Survivors | 2026-12-31 |
| NCT04332588University of Alabama at BirminghamMonitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI | 2027-08 |
| NCT03368729University of Alabama at BirminghamNiraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer | 2027-11-01 |
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Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\[89Zr\]-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.
Drug: [89Zr]-Df-Trastuzumab · Diagnostic Test: PET/MRI Imaging
\[89Zr\]-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.
5-6 days post injection the patients will undergo PET/MRI imaging.
This study also gives Trastuzumab. No intervention listed here names it: that was found by reading the record.
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.
Time frame: 24 months
Started Nov 2017 (actual). Primary completion is estimated for Oct 2028, 131 months after the start.
Of 372 non-industry phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 77. This study's planned 131 months is above that.
Counting every sponsor, half of 761 studies reached it within 44 months; a quarter within 25 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Zirconium-89
University of Alabama at Birmingham →