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

NCT05923177 | Completed Phase 1

• 1 other identifier: [123I] I-(HE)3-G3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Safety attributable to [123I] I-(HE)3-G3 injections (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)

  48 hours

• Safety attributable to [123I] I-(HE)3-G3 injections (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)

  48 hours

• Safety attributable to [123I] I-(HE)3-G3 injections (% of incidence and severity of adverse events)

  48 hours

Study Arms (1)

The tested injected doses of [123I] I-(HE)3-G3 3000 μg

EXPERIMENTAL

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

Interventions

SPECT DRUG

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.

Also known as: [123I] I-(HE)3-G3

The tested injected doses of [123I] I-(HE)3-G3 3000 μg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with primary breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years of age
• 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
• 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
• 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
• Subject is capable to undergo the diagnostic investigations to be performed in the study
• Informed consent

You may not qualify if:

• Any system therapy (chemo-/targeted therapy)
• Second, non-breast malignancy
• Active current autoimmune disease or history of autoimmune disease
• 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
• Administration of other investigational medicinal product within 30 days of screening
• Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Interventions

Iodine-123

Study Officials

• Olga Bragina, Dsc

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

RU (1)