[18F]GEH121224 Imaging for Advanced Breast Cancer

(HER2-1 Trial)

Overseen By Eduard Zhalovaga, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: GE Healthcare

Must not be taking: Anti-HER2 therapy

Disqualifiers: Non-breast malignancy, Hepatitis B/C, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and potential of a new imaging tracer, [18F]GEH121224, for diagnosing HER2-positive breast cancer. The goal is to evaluate its effectiveness in highlighting cancer lesions through PET scans, which could aid in detecting advanced cases. The trial includes two groups of patients to study how the tracer spreads in the body and whether the results remain consistent over time. Women with advanced or metastatic HER2-positive breast cancer, who have not received radiation treatment on their target lesion and meet other criteria, may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new imaging tracer.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic therapy, including anti-HER2 therapy, at least 2 weeks before enrolling. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What prior data suggests that [18F]GEH121224 is safe for use as a PET radiotracer in imaging advanced breast cancer?

Research shows that [18F]GEH121224 is still in the early stages of testing to determine its safety for humans. While the treatment appears promising, the current focus is on gathering safety information. As a Phase 1 trial, this marks the first time the treatment is tested in people. The primary goal is to assess its safety and how the body processes it.

Previous studies with similar substances used in scans (called radiotracers) have shown they can be safe and useful for diagnosing diseases. However, because [18F]GEH121224 is new, specific information on its tolerance and potential side effects is not yet available. Early phase trials like this one aim to identify any potential problems before proceeding to larger studies.

Participation helps scientists learn more about the safety of this new radiotracer, an important step in developing new tools for diagnosing advanced breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of [18F]GEH121224 for imaging advanced breast cancer because it offers a new way to visualize cancer spread in the body. Unlike traditional imaging techniques, this investigational compound uses a radioactive tracer that can highlight cancerous tissues with potentially greater precision. The trial explores both how the compound distributes in the body and the reliability of its imaging results, which could lead to more accurate diagnostics and better treatment planning for patients. This could be a game-changer in managing advanced breast cancer, making it easier to monitor disease progression and response to treatment.

What evidence suggests that [18F]GEH121224 is effective for imaging HER2 positive breast cancer?

Research has shown that [18F]GEH121224, which participants in this trial will receive, might be a useful tool for imaging HER2 positive breast cancer. Although specific data on [18F]GEH121224 is limited, similar substances used in PET scans have demonstrated promising results. For example, [18F]FES PET imaging was 81% accurate in detecting certain breast cancer markers and 86% accurate in ruling them out. These findings suggest that radiotracers like [18F]GEH121224 can effectively identify cancer features. The goal is to help doctors see cancer more clearly and make better treatment decisions, potentially improving the diagnosis and management of advanced breast cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Eduard Zhalovaga, MD, PhD

Principal Investigator

GE Healthcare Ltd

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am not pregnant and agree to use contraception for 3 weeks after receiving the treatment.

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

Exclusion Criteria

Pregnancy or breast-feeding or, for women of child-bearing potential, unwillingness to use an acceptable form of birth control

Known allergies to any product used in this study or any constituents of GEH121224 (18F) Injection

I do not have severe side effects from past cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry Study

Group 1 patients receive a single injection of GEH121224 (18F) and undergo dynamic and static PET/CT scans for dosimetry analysis

1 day

8 sequential scans over 90 minutes, followed by static scans at 120 and 240 minutes

Test-Retest Study

Group 2 patients receive two separate injections of GEH121224 (18F) and undergo PET imaging to assess reproducibility

3 weeks

2 imaging days, each with a single injection and PET imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 24-hour safety follow-up by phone after each dose

6 months

What Are the Treatments Tested in This Trial?

Interventions

• [18F]GEH121224

Trial Overview [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.

How Is the Trial Designed?

Group I: [18F]GEH121224 - Group 2 - Reproducibility Experimental Treatment 2 Interventions

Group II: [18F]GEH121224 - Group 1 - Biodistribution Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

Published Research Related to This Trial

Molecular imaging techniques like PET and SPECT can provide sensitive, non-invasive insights into breast cancer characteristics, aiding in screening, staging, and therapy guidance.

Specific imaging of breast cancer targets, such as estrogen receptors and HER2, has shown improved detection of tumors compared to conventional methods, indicating a promising future for these technologies in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular imaging of breast cancer. Oude Munnink, TH., Nagengast, WB., Brouwers, AH., et al.[2016]

Noninvasive imaging techniques like PET and SPECT can effectively identify and quantify therapeutic targets in breast cancer, aiding in the customization of treatment plans for patients based on their specific tumor characteristics.

The review analyzed 17 clinical studies on various imaging agents targeting different receptors in breast cancer, highlighting their potential role in guiding targeted therapies and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Nuclear Imaging Agents in Breast Cancer. Li, Z., Aboian, MS., Zhu, X., et al.[2022]

A meta-analysis of 11 studies involving 327 lesions showed that 18F-FES PET imaging has a sensitivity of 81% and specificity of 86% for assessing estrogen receptor status in metastatic breast cancer, indicating its effectiveness as a non-invasive diagnostic tool.

18F-FES PET could complement traditional tissue assays for determining ER status, potentially improving treatment decisions and outcomes for patients with metastatic breast cancer, especially in cases with brain metastases or lobular histology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Characterization of Estrogen Receptor Status in Metastatic Breast Cancer with 16α-18F-Fluoro-17β-Estradiol Positron Emission Tomography: Meta-Analysis and Recommendations for Integration into Clinical Applications. Kurland, BF., Wiggins, JR., Coche, A., et al.[2022]

Molecular imaging with PET is becoming increasingly important in breast cancer, with over 45 different PET tracers being tested, but currently only (18)F-FDG is widely used in clinical guidelines.

To effectively implement new PET tracers in clinical practice, standardization of technology and access to these tracers is essential, along with innovative research approaches to demonstrate their clinical value with fewer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. van Es, SC., Venema, CM., Glaudemans, AW., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05634954

NCT05634954 | Study to Evaluate Safety and Dosimetry of ... The results of this study will provide crucial information to guide the development of [18F]GEH121224 for the detection of HER2 status in advanced breast cancer ...

2. withpower.com withpower.com/trial/phase-1-breast-cancer-11-2022-57434

[18F]GEH121224 Imaging for Advanced Breast Cancer A meta-analysis of 11 studies involving 327 lesions showed that 18F-FES PET imaging has a sensitivity of 81% and specificity of 86% for assessing estrogen ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10192501/

Current status of contemporary diagnostic radiotracers in the ... In this narrative review, we focus on the current role of molecular imaging with contemporary radiotracers for positron emission tomography (PET) in breast ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354408/

Comparing the diagnostic efficacy of [18F]FDG PET/CT and ... This meta-analysis evaluates and compares the diagnostic accuracy of [18F]FDG PET/CT and [18F]FDG PET/MRI in detecting breast cancer ...

5. docwirenews.com docwirenews.com/post/imaging-effective-in-the-early-detection-of-metastatic-disease-in-early-stage-breast-cancer

Imaging Effective in the Early Detection of Metastatic ... Imaging modalities show significant efficacy in identifying metastasis among asymptomatic early-stage breast cancer.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT05634954

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

7. ancora.ai ancora.ai/fr/details/NCT05634954

Study to Evaluate Safety and Dosimetry of [18F] ... The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer.