Using Color Doppler US Artifact to Identify Tumor Markers

NCT06166173 | Unknown

• 1 other identifier: BREAST TM
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Before neoadjuvant chemotherapy (NACT) in cases of locally advanced breast cancer, malignant masses in the breast and biopsy-proven tumor involvement axillary lymph nodes are marked with metallic markers. The primary objective of this marking is to establish the precise localization of the tumor which response to NACT partial or completely. However, selecting the marker with ultrasound (US) proves challenging in many instances. Research studies indicate that patients with occult markers are observed at a frequency of 24%. Some studies propose that the twinkling artifact serves as a reliable method for accurately indicating the localization of certain tumor markers. This artifact is deemed particularly helpful for lesions situated in the axilla or posterior of the breast, which may not be visible with US and are undetectable with mammography. In the context of Color Doppler examination, the investigators have noted the presence of another color Doppler artifact which can aid in determining marker localization. When the pulse repetition frequency (PRF) is reduced and the color gain is increased, color noise, termed as color confusion or blooming artifact/effect, is observed within the color steer. While this color confusion tends to mask healthy tissues, it has been observed that the tumor marker remains unaffected by the blooming effect. Consequently, this artifact serves to distinctly reveal the borders and localization of the tumor marker. In some studies, it has been stated that the twinkling artifact, which is a color Doppler artifact and whose mechanism is not fully understood, is a reliable method to accurately indicate the localization of some tumor markers. It has been reported that this artifact will be very helpful, especially in lesions located in the axilla or posterior of the breast, which cannot be seen with US and cannot be detected with mammography . In Color Doppler examination, we saw that another color Doppler artifact, such as the twinkling artifact, could also be helpful in determining marker localization. When the PRF is reduced and the color gain is increased, color noise, which is selected as color confusion and can be called blooming artifact or blooming effect-like, is observed in all structures within the color steer. While healthy tissues are masked by this color confusion, the tumor marker is protected from the blooming effect. Thus, with this artifact, tumor marker borders and localization are clearly revealed.

Conditions

Breast Cancer; Interventional Radiology; Doppler Ultrasound

Keywords

breast cancer; tumor marker; doppler ultrasound; neoadjuvan chemotherapy

Outcome Measures

Primary Outcomes (1)

• Easier localization of breast tumor marker with Doppler ultrasound findings in approximately 20 patients

  Use of Doppler US artifacts as an auxiliary diagnostic method in cases where tumor markers in the breast and axilla cannot be detected with conventional US.

  through study completion, an average of 6 months

Study Arms (1)

Breast tumor

Female patients with breast tumors and/or axillary lymph node metastases who had markers placed before neoadjuvant chemotherapy (NACT), and patients undergoing preoperative marker localization after NACT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with breast cancer and/or pathologically proven axillary lymph node involvement and who are planned or have received NACT

You may qualify if:

• patients who have breast cancer and will receive NACT,
• patients who are scheduled for breast-conserving surgery,
• those who are not allergic to metals

You may not qualify if:

• patients with breast cancer for whom NACT is not planned,
• patients with bleeding disorders, patients with metallic allergies,
• patients with cooperation problems and those who cannot remain still during US

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 12, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

TU (1)