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Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

NCT05203497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-21

No results posted yet for this study

Summary

The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer

The primary objectives are:

1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
2. To evaluate dosimetry of 99mTc-ZHER2:41071;
3. To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:

The secondary objectives are:

1\. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Conditions

  • Breast Cancer Female

Interventions

DRUG

SPECT

One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Vladimir Chernov, MD, Prof. · 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
2021-12-22
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Russia

Study Locations

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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 NCT05203497 on ClinicalTrials.gov