A Clinical Feasibility Study of a Photoacoustic Finder

NCT06412211 | Active Not Recruiting

• 1 other identifier: KC21DIDT0810
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Determining the prognosis of breast cancer relies significantly on axillary staging by sentinel lymph node biopsy (SLNb). The SLNb is generally performed using radioisotopes, blue dyes, or both to improve the false negative rate. However, a gamma probe with radioisotopes involves ionizing radiation, and blue dye detection relies on visual inspection by an operator. To overcome these limitations, the photoacoustic finder (PAF) was developed as a highly sensitive, non-radioactive detector that uses only blue dye and a photoacoustic signal to detect SLNs. To evaluate the PAF, its performance was compared with the standard SLN detection method for breast cancer patients.

Conditions

Sentinel Lymph Node; Breast Cancer

Keywords

Photoacoustic; Sentinel lymph node detection

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection (SLN) rate

  Number of detected SLNs / Number of total resected LNs

  during the surgery

Study Arms (1)

SLN resected patients

Patients with breast cancer underwent sentinel lymph node biopsy

Device: Photoacoustic finder

Interventions

Photoacoustic finder DEVICE

Sentinel lymph node detector using photoacoustic signal

SLN resected patients

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A woman is diagnosed with breast cancer at St Mary's Hospital, Seoul.

You may qualify if:

• age between 19 and 74 years
• histologically confirmed invasive breast cancer or intraepithelial carcinoma
• no clinical suspicion of axillary LN metastasis

You may not qualify if:

• Previously undergone ipsilateral breast
• Axillary surgery
• Received chemotherapy prior to surgery
• who were unable to undergo SLN biopsy
• who had confirmed axillary LN metastasis by histologic examination
• who had breast cancer while lactating or pregnant

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Pohang University of Science and Technology: collaborator

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 07345, South Korea

Location

Related Publications (13)

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  PMID: 17513820 BACKGROUND

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  PMID: 20863759 BACKGROUND

• Petrelli F, Lonati V, Barni S. Axillary dissection compared to sentinel node biopsy for the treatment of pathologically node-negative breast cancer: a meta-analysis of four randomized trials with long-term follow up. Oncol Rev. 2012 Oct 8;6(2):e20. doi: 10.4081/oncol.2012.e20. eCollection 2012 Oct 2.

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  PMID: 22569745 BACKGROUND

• Wang Z, Wu LC, Chen JQ. Sentinel lymph node biopsy compared with axillary lymph node dissection in early breast cancer: a meta-analysis. Breast Cancer Res Treat. 2011 Oct;129(3):675-89. doi: 10.1007/s10549-011-1665-1. Epub 2011 Jul 9.

  PMID: 21743996 BACKGROUND

• Park B, Han M, Park J, Kim T, Ryu H, Seo Y, Kim WJ, Kim HH, Kim C. A photoacoustic finder fully integrated with a solid-state dye laser and transparent ultrasound transducer. Photoacoustics. 2021 Aug 4;23:100290. doi: 10.1016/j.pacs.2021.100290. eCollection 2021 Sep.

  PMID: 34401325 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dooreh Kim, MD

  Seoul St. Mary's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: December 7, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Receive the data request via the registered email, verify the identity (for example, Relevant researcher), and provide the data.

Locations

KR (1)