NCT02340468

Brief Summary

In the field of cancer treatment, it is generally accepted that the enhancement of oxygen delivery to tumors can augment the effect of anti-cancer therapies. In the case of chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment reaching the tumor and having an effect.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

January 13, 2015

Last Update Submit

October 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure breast tumor oxygenation

    up to 12 weeks

Interventions

diffuse optical spectroscopy

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will be recruited from an outpatient at UC Irvine Health

You may qualify if:

  • Tumor group, female, Greater than 21 years of age but less than 70 years of age, Current diagnosis of breast cancer stage 0 - IV or radiologically suspicious for breast cancer BI-RADS score 4 or 5.
  • Control group,Female, Greater than 21 years of age but less than 70 years of age, Not currently diagnosed with breast cancer

You may not qualify if:

  • Under 21 years of age, Pregnant or breastfeeding, Contraindications for moderate exercise, history of heart, pulmonary, or musculoskeletal disease; physician instructions to restrict physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bruce Tromberg, PhD

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations