Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Iodine -123-labelled Designed Ankyrin Repeat Proteins HE3-G3 ([123I] I-(HE)3-G3)

The study should evaluate distribution of [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer

Study Overview

• Status: Completed
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: SPECT

Detailed Description

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.

Phase I. Distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation
    • TomskNRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is > 18 years of age
2. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative

3. Hematological, liver and renal function test results within the following limits:

   • White blood cell count: > 2.0 x 109/L
   • Hemoglobin: > 80 g/L
   • Platelets: > 50.0 x 109/L
   • ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
   • Bilirubin =< 2.0 times Upper Limit of Normal
   • Serum creatinine: Within Normal Limits
4. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The tested injected doses of [123I] I-(HE)3-G3 3000 μg; At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. Subjects withdrawn from the study for any reason will be replaced	Drug: SPECT; One single injection of [123I] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.; Other Names: [123I] I-(HE)3-G3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gamma camera-based whole-body [123I] I-(HE)3-G3 uptake value (%)	Whole-body [123I] I-(HE)3-G3 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical	6 hours
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts	SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts	6 hours
SPECT-based [123I] I-(HE)3-G3 background uptake value (counts)	Focal uptake of [123I] I-(HE)3-G3 in the regions without pathological findings will be assessed with SPECT and measured in counts	6 hours
Tumor-to-background ratio (SPECT)	The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [123I] I-(HE)3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of [123I] I-(HE)3-G3 uptake coinciding with the regions without pathological findings (counts)	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety attributable to [123I] I-(HE)3-G3 injections (physical examination) (% of cases with abnormal findings relative to baseline)	The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)	48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (vital signs) (% of cases with abnormal findings relative to baseline)	The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)	48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (ECG) (% of cases with abnormal findings relative to baseline)	The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)	48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (laboratory tests) (% of cases with abnormal findings relative to baseline)	The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)	48 hours
Safety attributable to [123I] I-(HE)3-G3 injections (% of incidence and severity of adverse events)	The safety attributable to [123I] I-(HE)3-G3 injections will be evaluated based on the rate of adverse events (%)	48 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Olga Bragina, Dsc, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: [123I] I-(HE)3-G3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No