Automated Method for Breast Cancer Detection

NCT03863522 | Terminated Results FDA Device

• 2 other identifiers: J18138IRB00172441
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.

Conditions

Breast Cancer Diagnosis

Keywords

Breast Cancer Diagnosis; Ultrasound-guided core needle biopsy; Fine needle aspiration; FNA; Diagnostic Cartridge

Outcome Measures

Primary Outcomes (2)

• Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion

  Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.

  up to 2 years

• Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)

  Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology

  up to 2 years

Secondary Outcomes (3)

• Correlation of Diagnostic Cartridge With Known Lab Assay

  up to 2 years

• Correlation of Known Lab Assay for FNA Versus the Core Biopsy

  up to 2 years

• Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections

  up to 2 years

Study Arms (1)

Fine Needle Aspiration

OTHER

Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).

Procedure: Fine needle aspiration; Device: Cancer Detection cartridge

Interventions

Fine needle aspiration PROCEDURE

Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.

Also known as: FNA

Fine Needle Aspiration

Cancer Detection cartridge DEVICE

The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis.

Fine Needle Aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be female
• Patient must be 18 years of age or older
• Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

You may not qualify if:

• Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

Johns Hopkins Hospital Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Medical Imaging at Green spring Station

Lutherville-Timonium, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Limitations and Caveats

Enrollment was halted early due to the quality of samples obtained. Samples contained insufficient cells and could not be analysed.

Results Point of Contact

• Title: Dr. Sara Sukumar
• Organization: Johns Hopkins University

saras@jhmi.edu

4106142479

Study Officials

• Lisa Mullen, MD

  JHU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: March 7, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: November 19, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)