MedTrace Logo

Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy

NCT04468113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 339

Last updated 2023-11-24

No results posted yet for this study

Summary

Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.

The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.

Conditions

  • Primary Breast Cancer

Interventions

DEVICE

Tumark® Vision clip

Suspicious intramammary lesion is marked with clip

Sponsors & Collaborators

  • Kliniken Essen-Mitte

    lead OTHER

Principal Investigators

  • Sherko Kuemmel, MD, PhD · Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

  • Mattea Reinisch, MD · Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany

  • Jörg Heil, MD, PhD · Department of Gynecology, Breast Center, Heidelberg University, Germany

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2023-03-30
Completion
2023-07-30

Countries

  • Germany

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 NCT04468113 on ClinicalTrials.gov