NCT04277338: HE3-G3

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3

Completed Phase 1 Last updated 6 October 2021

What this trial tests

Phase 1 trial testing SPECT in Primary Breast Cancer in 30 participants. Completed in 4 October 2021.

Timeline

10 February 2020

Primary endpoint
10 February 2021

4 October 2021

Quick facts

Lead sponsor	Tomsk National Research Medical Center of the Russian Academy of Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	30
Start date	10 February 2020
Primary completion	10 February 2021
Estimated completion	4 October 2021
Sites	1 location across Russia

Drugs / interventions tested

• SPECT — full drug profile →

Conditions studied

• Primary Breast Cancer — all drugs for Primary Breast Cancer →

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Who can join

Adults 18 to 80, female only, with Primary Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;
2. To evaluate dosimetry of 99mTc-HE3-G3;
3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection:

The secondary objective are:

1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I Trial of ^99mTc-(HE)₃-G3, a DARPin-Based Probe for Imaging of HER2 Expression in Breast Cancer.
   Bragina O, Chernov V, Schulga A, Konovalova E, et al · · 2022 · cited 41× · PMID 34385343 · DOI 10.2967/jnumed.121.262542
2. Protein scaffolds: antibody alternatives for cancer diagnosis and therapy.
   Luo R, Liu H, Cheng Z. · · 2022 · cited 37× · PMID 35866165 · DOI 10.1039/d2cb00094f
3. PET and SPECT Imaging of the EGFR Family (RTK Class I) in Oncology.
   Rinne SS, Orlova A, Tolmachev V. · · 2021 · cited 22× · PMID 33915894 · DOI 10.3390/ijms22073663
4. Preclinical evaluation of EpCAM-binding designed ankyrin repeat proteins (DARPins) as targeting moieties for bimodal near-infrared fluorescence and photoacoustic imaging of cancer.
   Houvast RD, Badr N, March T, de Muynck LDAN, et al · · 2024 · cited 10× · PMID 37642704 · DOI 10.1007/s00259-023-06407-w
5. Direct Intra-Patient Comparison of Scaffold Protein-Based Tracers, [^99mTc]Tc-ADAPT6 and [^99mTc]Tc-(HE)₃-G3, for Imaging of HER2-Positive Breast Cancer.
   Bragina O, Chernov V, Schulga A, Konovalova E, et al · · 2023 · cited 7× · PMID 37370758 · DOI 10.3390/cancers15123149