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Light-Scattering Spectroscopy for Detection of Breast Cancer

Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01755208
Enrollment
110
Registered
2012-12-24
Start date
2012-11-21
Completion date
2020-11-19
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Brief summary

This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

Detailed description

PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer. OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Interventions

Undergo light-scattering spectroscopy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participants who are breast cancer free (mammogram negative within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants. * Provision of informed consent prior to any study-related procedures

Exclusion criteria

* Females with tattoos on either or both breasts * Females with nipple piercings on either or both breasts * Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts * Females unable to provide informed consent * Females s/p treatment for breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Accurate classifications of women with or without breast cancerUp to 1 yearExact binomial probabilities will be used.
Utility of optical markers in distinguishing cancer involved breasts from normal breastsUp to 1 yearMultivariate analyses will be used.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026