Clinical trial NCT05923177: Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Breast Cancer
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gamma camera-based whole-body [123I] I-(HE)3-G3 uptake value (%)
timeFrame: 6 hours
measure: 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
timeFrame: 6 hours
measure: SPECT-based [123I] I-(HE)3-G3 background uptake value (counts)
timeFrame: 6 hours
measure: Tumor-to-background ratio (SPECT)
timeFrame: 6 hours
Secondary outcomes:
measure: Safety attributable to [123I] I-(HE)3-G3 injections (physical examination) (% of cases with abnormal findings relative to baseline)
timeFrame: 48 hours
measure: Safety attributable to [123I] I-(HE)3-G3 injections (vital signs) (% of cases with abnormal findings relative to baseline)
timeFrame: 48 hours
measure: Safety attributable to [123I] I-(HE)3-G3 injections (ECG) (% of cases with abnormal findings relative to baseline)
timeFrame: 48 hours
measure: Safety attributable to [123I] I-(HE)3-G3 injections (laboratory tests) (% of cases with abnormal findings relative to baseline)
timeFrame: 48 hours
measure: Safety attributable to [123I] I-(HE)3-G3 injections (% of incidence and severity of adverse events)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: Tomsk NRMC
name: Olga Bragina, Dsc
role: PRINCIPAL_INVESTIGATOR
References: