NCT04332588 Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
| NCT ID | NCT04332588 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2022-03-25 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.
Eligibility Criteria
Inclusion Criteria: 1. Patients must be ≥ 18 years old and ≤ 75 years old 2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and/or positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility 3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment 4. Estimated life expectancy of greater than one year 5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter) Exclusion Criteria: 1. Inability to provide informed consent F 2. Weight over 350 lbs., due to the scanner bore size 3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study. 4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos) 5. Unable to lie still on the imaging table for one (1) hour 6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
Contact & Investigator
Jonathan McConathy, MD, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT04332588 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04332588 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04332588 currently recruiting?
Yes, NCT04332588 is actively recruiting participants. Contact the research team at asorace@uabmc.edu for enrollment information.
Where is the NCT04332588 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT04332588 clinical trial?
NCT04332588 is sponsored by University of Alabama at Birmingham. The principal investigator is Jonathan McConathy, MD, PhD at University of Alabama at Birmingham. The trial plans to enroll 25 participants.
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