NCT04242277

Brief Summary

This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2021

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

January 23, 2020

Last Update Submit

May 17, 2023

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • WF-OCT image acquisition of excised lumpectomy tissue margins

    This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.

    1 year

Study Arms (1)

WF-OCT imaging of excised breast lumpectomy tissue

Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired.

Device: Investigational WF-OCT device

Interventions

Investigational WF-OCT deviceDEVICE

Excised lumpectomy tissue will be imaged on an investigational WF-OCT device

WF-OCT imaging of excised breast lumpectomy tissue

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consented patients meeting eligibility criteria, undergoing breast conservation surgery.

You may qualify if:

  • Female
  • Age 18 years or older
  • Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
  • May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Metastatic cancer (Stage IV)
  • Lobular carcinoma as primary diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

  • Savitri Krishnamurthy, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

August 3, 2020

Primary Completion

July 27, 2021

Study Completion

July 27, 2021

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

US(2)