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Breast CancerPhase 1NCT05634954

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

A Phase 1 study testing GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan and Static - PET/CT Scan in people with Breast Cancer, run by GE Healthcare at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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 for the diagnostic imaging of HER2 positive breast cancer lesions. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan and Static - PET/CT Scan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2026to Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged ≥18 years
  • Willingness and ability to comply with study procedures and signed and dated informed consent
  • For women of child-bearing potential, negative urine pregnancy test at screening and o on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration) and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of [18F]GEH121224
  • Life expectancy >3 months
  • Diagnosis of locally advanced or metastatic breast cancer
  • Target lesion diameter of ≥15 mm that has not been previously treated with radiotherapy
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  • Histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the past 12 months confirming HER2-positive status by either IHC or FISH from primary tumor
  • Previously received no more than 1 prior lines of systemic chemotherapy (including anti HER2 therapy) for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Adequate organ function as defined by:
  • Hemoglobin ≥10 g/dL White blood cell count ≥3.0 × 109/L Platelet count ≥75 × 109/L Serum creatinine ≤1.4 mg/dL Aspartate aminotransferase and alanine aminotransferase ≤2× upper limit of normal (ULN) Total bilirubin ≤2× ULN or 3.0 mg/dL in patients with Gilbert's syndrome
  • At least one lesion is fluorodeoxyglucose (FDG)-avid

Who cannot join

  • Patient has a primary non-breast malignancy (small dermatological malignancies such as basal cell carcinoma <10 mm are allowed)
  • Pregnancy or breast-feeding or, for women of child-bearing potential, unwillingness to use an acceptable form of birth control
  • Chronically active hepatitis B or C
  • Current history of drug or alcohol abuse or any active liver disease
  • Administration of other IMP within 30 days of screening
  • Systemic therapy including anti-HER2 therapy within 2 weeks before enrollment
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  • Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis)
  • Evidence of significant medical condition, ongoing severe disease, or laboratory finding that, in the opinion of the Investigator, makes it undesirable for the patient to participate in the study
  • Severe claustrophobia, inability to lie flat or fit into the scanner (e.g., body weight ≥350 lbs [160 kg]), or any other inability to tolerate the PET scan
  • Known allergies to any product used in this study or any constituents of GEH121224 (18F) Injection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas MD Anderson Cancer Centre

    Houston, Texas, 77030-4008

Other trials in United States

About this study

Official title: A Phase 1 Study to Assess the Safety, Radiation Dosimetry and Biodistribution, and Basic Pharmacokinetics of [18F]GEH121224 and Determine the Optimal Timing of Imaging in Patients With Locally Advanced or Metastatic Breast Cancer.

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 for the diagnostic imaging of HER2 positive breast cancer lesions. A group of 6 patients will be selected to perform a dosimetry study with [18F]GEH121224 followed by another group of 6 patients in a test-retest study. 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 patients. This study will use established methods for characterizing the radiation dosimetry, biodistribution and basic pharmacokinetics of a radiotracer.

Read the detailed description

Group 1 : Six female patients with locally advanced or metastatic breast cancer and with HER2-positive primary tumor status will be included. These patients will receive a single injection of GEH121224 (18F) Injection and will then undergo a dynamic whole-body PET/CT scan starting at the time of injection (8 sequential scans over 90 minutes anticipated) followed by static whole-body scans starting at 120 minutes and 240 minutes after injection. Blood samples will be collected at specified time points during imaging for pharmacokinetic analysis. Safety and imaging data will be reviewed on an ongoing basis after dosing of each patient in Group 1. The injected activity may be adjusted for subsequent patients in Group 1 based on this review. A complete aggregate review of safety and imaging data will be performed by the Sponsor once all 6 patients in Group 1 have been dosed. If no safety concerns are raised, enrollment into Group 2 will start. The injected radioactivity may also be optimized before enrolling patients in Group 2. Review of safety data is described in the Safety Data Review Plan.

Group 2 : Six female patients with locally advanced or metastatic breast cancer and with HER2-positive primary tumor status will be included in Group 2 and will receive a single injection of GEH121224 (18F) Injection on each of 2 separate days. On Imaging Day 1, patients will receive a single injection of GEH121224 (18F) Injection and will then undergo [18F]GEH121224 PET imaging at the optimal scan time identified in Group 1. Within 3 weeks (3 to 21 days; Imaging Day 2), patients will receive a second single injection of GEH121224 (18F) Injection and again undergo [18F]GEH121224 PET imaging at the optimal scan time identified in Group 1.

Patient safety will be monitored throughout the course of the study, including a 24-hour safety follow-up by phone after each dose of [18F]GEH121224.

Conditions
Breast Cancer
Being tested
GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan, Static - PET/CT Scan
Keywords
HER2 positive, Breast Oncology
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEH121224 (18F) InjectionDrug

    Single GEH121224 (18F) Injection

  • Dynamic and Static - PET/CT ScanDiagnostic test

    Group 1: Dynamic whole-body PET/CT scan will start at the time of injection (8 sequential scans over 90 minutes anticipated) followed by static whole-body scans starting at 120 minutes and 240 minutes after injection.

  • Static - PET/CT ScanDiagnostic test

    Group 2: Static whole-body scans

Study groups in NCT05634954
Study groupRoleWhat they receive
[18F]GEH121224 - Group 1 - BiodistributionExperimentalNot described
Receives: Drug: GEH121224 (18F) Injection; Diagnostic Test: Dynamic and Static - PET/CT Scan
[18F]GEH121224 - Group 2 - ReproducibilityExperimentalNot described
Receives: Drug: GEH121224 (18F) Injection; Diagnostic Test: Static - PET/CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specific absorbed dose to the target lesions, specific absorbed dose per organ, and total effective dose of [18F]GEH121224.

    Measured: 6 months

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

    The occurrence of post-administration injection site status outside the normal limits will be summarized.

    Measured: Before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

  3. Occurrence of Adverse Events (AEs) following administration of [18F]GEH121224

    An overall summary of AEs, SAEs, and [18F]GEH121224-emergent AEs will be presented, coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class and preferred term.

    Measured: 6 months

  4. Changes in heart rate as beats per minute following administration of [18F]GEH121224

    The occurrence of post-administration heart rate values outside the normal limits will be summarized.

    Measured: Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

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

    The occurrence of post-administration blood pressure values outside the normal limits will be summarized.

    Measured: Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

  6. Changes in temperature as degree C following administration of [18F]GEH121224

    The occurrence of post-administration body temperature values outside the normal limits will be summarized.

    Measured: Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

  7. Changes in respiration rate as breaths per minute following administration of [18F]GEH121224

    The occurrence of post-administration respiration rate values outside the normal limits will be summarized.

    Measured: Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

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

    Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (PR, QTc, QRS or RR).

    Measured: Baseline, before [18F]GEH121224 administration, immediately after single whole body PET/CT scans

Secondary outcomes (2)

  1. Biodistribution

    Time-activity curves will be generated and integrated to obtain the cumulated activity in each region, and these values will be used to determine the internal radiation dosimetry using the Medical Internal Radiation Dose (MIRD) schema.

    Measured: 6 months

  2. Reproducibility

    Variation in the relative standardized uptake values (SUVs) calculated from test and retest [18F]GEH121224 PET images.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study startFeb 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Model description
Patients will be enrolled into 1 of 2 groups in a sequential manner. Group 1 will allow to study \[18F\]GEH121224 Biodistribution and Radiation Dosimetry. Group 2 will allow to study \[18F\]GEH121224 PET/CT Scan Test Retest.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634954
Sponsor's protocol ID
GE-226-004
Status last verified
Oct 2025
First submitted
22 Nov 2022
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEH121224 (18F) Injection, Dynamic and Static - PET/CT Scan and Static - PET/CT Scan in people with Breast Cancer, run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specific absorbed dose to the target lesions, specific absorbed dose per organ, and total effective dose of [18F]GEH121224. (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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