MedTrace Logo

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

NCT04277338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Primary Breast Cancer

Interventions

DRUG

SPECT

One single injection of 99mTc-HE3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.

Sponsors & Collaborators

  • Institute of Bioorganic Chemistry, Russian Academy of Sciences

    collaborator UNKNOWN

  • Uppsala University

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Vladimir I Chernov · Tomsk NRMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-02-10
Completion
2021-10-04

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277338 on ClinicalTrials.gov