NCT01755130

Brief Summary

This clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has spread.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 13, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

7.1 years

First QC Date

December 18, 2012

Last Update Submit

June 24, 2021

Conditions

Breast NeoplasmInflammatory Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)

    Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.

    Within 7 days of the standard of care ultrasound

  • False positive rate of LOUISA 3D and standard of care ultrasound

    McNemar's test will be used to compare paired proportions and relative false positive rates.

    Within 7 days of the standard of care ultrasound

Study Arms (1)

Diagnostic (LOUISA 3D)

EXPERIMENTAL

Patients undergo LOUISA 3D over approximately 30 minutes on the same day or within 7 days of any breast imaging procedure and within 7 days before biopsy.

Procedure: Photoacoustic Imaging

Interventions

Photoacoustic ImagingPROCEDURE

Undergo LOUISA 3D

Diagnostic (LOUISA 3D)

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mass palpable or nonpalpable
  • Tissue density - all tissue types
  • Menses - any stage of cycle
  • Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion\[s\])
  • Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
  • Any tumor type (patients with inflammatory breast cancer may be included)

You may not qualify if:

  • Patient is unable or unwilling to give informed consent for any reason
  • Disability (psychiatric, neurological or physical, which precludes examination)
  • Patient has tattoos on the region of interest
  • Overweight over 250 pounds (LB)
  • Very large breast size exceeding 6 inch diameter
  • Patient has body piercing jewelry through the nipple that cannot be removed
  • Patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post biopsy \[bx\] change may be included)
  • Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast
  • Patient has any pain or high sensitivity in the breast
  • Currently taking hormonal replacement therapy
  • Non-ambulatory or unable to comply with exam
  • Pregnant (pregnancy test is not required, only as confirmed by patient)
  • Breastfeeding
  • Prior breast treatment for target lesion
  • Previous surgery of the breast in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wei Yang

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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

December 18, 2012

First Posted

December 24, 2012

Study Start

May 13, 2014

Primary Completion

June 2, 2021

Study Completion

June 2, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

US(1)