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99mTc-ADAPT6-based HER2 Imaging in Breast Cancer

NCT03991260 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-04-01

No results posted yet for this study

Summary

The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. To assess kinetics of 99mTc- ADAPT6 in blood;
3. To evaluate dosimetry of 99mTc- ADAPT6;
4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:

The secondary objective is:

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

Interventions

DIAGNOSTIC_TEST

SPECT

One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

Sponsors & Collaborators

  • KTH Royal Institute of Technology

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Vladimir I Chernov, MD, Prof. · TomskNMRC

Eligibility

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

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2020-06-05
Completion
2020-09-05

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT03991260 on ClinicalTrials.gov