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[18F]GEH121224 Imaging for Advanced Breast Cancer (HER2-1 Trial)

Phase 1

Waitlist Available

Research Sponsored by GE Healthcare

Eligibility Criteria Checklist

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

Must have

Previously received no more than 1 prior lines of systemic chemotherapy (including anti HER2 therapy) for metastatic breast cancer

Target lesion diameter of ≥15 mm that has not been previously treated with radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

HER2-1 Trial Summary

This trial will test a new imaging method for detecting advanced breast cancer and assess its safety and potential. 6 patients will be studied to evaluate radiation dosimetry and 6 more in a test-retest study. Results will help guide the development of this imaging method.

Who is the study for?

This trial is for women over 18 with advanced HER2-positive breast cancer who've had no more than one chemotherapy treatment. They must be willing to follow study rules, not be pregnant or breastfeeding, and use contraception post-injection. Participants need good organ function and a life expectancy over three months.Check my eligibility

What is being tested?

[18F]GEH121224 is being tested as a PET scan tracer for detecting HER2 in breast cancer. The Phase 1 trial involves two small groups of patients: one for dosimetry studies and another for test-retest reliability, assessing the tracer's safety and pharmacokinetics.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include reactions related to the injection of [18F]GEH121224 or discomfort from undergoing PET/CT scans.

HER2-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I have had only one chemotherapy treatment for my breast cancer that has spread.

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My cancer has a large lesion that hasn't been treated with radiation.

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My breast cancer has spread beyond the initial area.

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My breast cancer is advanced or has spread, and a recent test confirmed it's HER2 positive.

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Your blood and organ function levels need to be within normal ranges. This means your hemoglobin, white blood cell count, platelet count, and other tests need to be at certain levels.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a woman aged 18 or older.

HER2-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of [18F]GEH121224

Change in injection site status following administration of [18F]GEH121224

Changes in blood pressure in mmHg following administration of [18F]GEH121224

+5 more

Secondary outcome measures

Biodistribution

Reproducibility

HER2-1 Trial Design

2Treatment groups

Experimental Treatment

Group I: [18F]GEH121224 - Group 2 - ReproducibilityExperimental Treatment2 Interventions

Group II: [18F]GEH121224 - Group 1 - BiodistributionExperimental Treatment2 Interventions

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

GE HealthcareLead Sponsor

291 Previous Clinical Trials

631,084 Total Patients Enrolled

32 Trials studying Breast Cancer

18,725 Patients Enrolled for Breast Cancer

Laboratory Corporation of AmericaIndustry Sponsor

27 Previous Clinical Trials

9,873 Total Patients Enrolled

Eduard Zhalovaga, MD, PhDStudy DirectorGE Healthcare Ltd

Media Library

Breast Cancer Clinical Trial 2023: [18F]GEH121224 - Group 1 - Biodistribution Highlights & Side Effects. Trial Name: NCT05634954 — Phase 1

Frequently Asked Questions

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

Are recruitment efforts still underway for this trial?

"According to the data on clinicaltrials.gov, this study is not currently open for recruitment of participants; its first posting was on December 1st 2022 and it last updated November 22nd 2022. Nevertheless, there are still 2603 other trials actively seeking subjects at present."

Answered by AI

Has the FDA granted approval for [18F]GEH121224 - Group 2 - Reproducibility?

"Our Power team estimated the safety of [18F]GEH121224 - Group 2 - Reproducibility to be a 1 due to its Phase 1 status, which implies limited data exists on both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer

2025. "Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05634954.