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89Zr-Trastuzumab PET Imaging for Breast Cancer

Q: How extensive is the participant pool for this clinical trial?

Affirmative. Clinicaltrials.gov confirms that this trial is enrolling participants, having first been posted on November 21st 2017 and most recently updated February 1st 2022. The total number of individuals needed across one location stands at 10.

Q: Is enrollment for this research still available?

Affirmative. Information on clinicaltrials.gov attests to the ongoing recruitment of patients for this medical trial, which was first listed on November 21st 2017 and recently modified in February 1st 2022. The study needs 10 participants from a single site.

Q: To what pathologies does PET/MRI Imaging typically provide a viable solution?

<a href="https://www.withpower.com/clinical-trials/breast-cancer">Breast cancer</a> patients often turn to PET/<a href="https://www.withpower.com/clinical-trials/mri">MRI</a> imaging for treatment. Nevertheless, this diagnostic method is also instrumental in treating other conditions such as high risk of recurrence, first line treatments and surgery.

Phase < 1

Recruiting

Led By Suzanne E Lapi, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent

Be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new way to image breast cancer tumors using 89Zr-trastuzumab to see if it can predict which patients are likely to respond to targeted HER2 agents as single agent therapy.

Who is the study for?

This trial is for adults over 18 with HER2 positive breast cancer, meeting specific diagnostic criteria. They should be in good physical condition (ECOG status of 0 or 1) and have a heart ejection fraction above 50%. It's not suitable for those who can't undergo MRI, are pregnant, unable to consent, cannot stay still for imaging, or weigh more than 350 lbs.Check my eligibility

What is being tested?

The study tests if PET/MRI imaging using [89Zr]-Df-Trastuzumab can predict the effectiveness of targeted HER2 therapy in breast cancer patients. The goal is to see if the uptake of this tracer correlates with laboratory measures of HER2 and response to treatment.See study design

What are the potential side effects?

While the document doesn't list specific side effects from [89Zr]-Df-Trastuzumab PET/MRI imaging, potential risks may include allergic reactions to tracers or discomfort during scanning. Standard MRI-related side effects like anxiety in confined spaces could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for treatment that targets the HER2 protein in my cancer.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My breast cancer is HER2 positive according to specific guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent

Trial Design

1Treatment groups

Experimental Treatment

Group I: [89Zr]-Df-TrastuzumabExperimental Treatment2 Interventions

[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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,593 Previous Clinical Trials

2,282,672 Total Patients Enrolled

31 Trials studying Breast Cancer

4,481 Patients Enrolled for Breast Cancer

Suzanne E Lapi, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

PET/MRI Imaging Clinical Trial Eligibility Overview. Trial Name: NCT03321045 — Phase < 1

Breast Cancer Research Study Groups: [89Zr]-Df-Trastuzumab

Breast Cancer Clinical Trial 2023: PET/MRI Imaging Highlights & Side Effects. Trial Name: NCT03321045 — Phase < 1

PET/MRI Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03321045 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the participant pool for this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this trial is enrolling participants, having first been posted on November 21st 2017 and most recently updated February 1st 2022. The total number of individuals needed across one location stands at 10."

Answered by AI

Is enrollment for this research still available?

"Affirmative. Information on clinicaltrials.gov attests to the ongoing recruitment of patients for this medical trial, which was first listed on November 21st 2017 and recently modified in February 1st 2022. The study needs 10 participants from a single site."

Answered by AI

To what pathologies does PET/MRI Imaging typically provide a viable solution?

"Breast cancer patients often turn to PET/MRI imaging for treatment. Nevertheless, this diagnostic method is also instrumental in treating other conditions such as high risk of recurrence, first line treatments and surgery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Suzanne E. Lapi, PhD 2017. "Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03321045.