[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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new imaging substance called [18F]GEH121224 in female patients with advanced HER2-positive breast cancer. The substance helps highlight cancer cells during a PET scan, making them easier to detect and study.

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.

How does [18F]GEH121224 imaging differ from other treatments for advanced breast cancer?

[18F]GEH121224 imaging is unique because it uses a radioactive tracer to visualize estrogen receptor activity in breast cancer, which can help in assessing the presence and spread of cancer non-invasively. This approach is different from traditional treatments as it focuses on imaging rather than directly treating the cancer, providing valuable information for tailoring treatment strategies. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment [18F]GEH121224 for advanced breast cancer?

The research highlights the potential of PET imaging agents, like [18F]GEH121224, in identifying breast cancer subtypes and guiding treatment decisions. PET imaging has been shown to help in detecting specific cancer characteristics, which can be crucial for selecting targeted therapies. ^{5 6 7 8 9}

Research Team

Eduard Zhalovaga, MD, PhD

Principal Investigator

GE Healthcare Ltd

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Developments in single photon emission computed tomography and PET-based HER2 molecular imaging for breast cancer. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Nuclear Imaging Agents in Breast Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Molecular imaging using PET and SPECT for identification of breast cancer subtypes. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular imaging of breast cancer. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Imaging Early-Stage Metastases Using an 18F-Labeled VEGFR-1-Specific Single Chain VEGF Mutant. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[18F]Fluorinated estradiol derivatives for oestrogen receptor imaging: impact of substituents, formulation and specific activity on the biodistribution in breast tumour-bearing mice. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Initial Clinical Results of a Novel Immuno-PET Theranostic Probe in Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. [2021]

9. England 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. [2022]