Development of a Quantitative Tissue Optical Index of Breast Density For Prediction of Hormone Therapy Response

NCT01773551 | Withdrawn

• 1 other identifier: 20128714
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. If decreased density can be reliably detected, it may help determine which subjects will benefit by taking tamoxifen or other chemoprevention drugs.

Conditions

Accessory; Breast Tissue

Outcome Measures

Primary Outcomes (1)

• Breast Density

  Breast Density

  up to 18 months

Study Arms (1)

Optical Index of Breast Density

Breast Density

Other: Breast Density

Interventions

Breast Density OTHER

Development of a Quantitative Tissue Optical Index of Breast Density

Optical Index of Breast Density

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Two groups of subjects will be recruited: 1. Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated) 2. Pre-menopausal women who will not receive any chemoprevention drug (control)

Treatment Group Inclusion Requirements 1. Premenopausal or peri-menopausal female older than 21 years of age 2. Elect to undergo, but have not yet started tamoxifen therapy; 3. Not pregnant and willing to use adequate contraception for the duration of study participation; and 4. Willing to avoid oral contraception use (which is not recommended while on tamoxifen treatment) for the duration of the study participation. Normal Group Inclusion Requirements 1. Premenopausal or peri-menopausal female older than 21 years of age 2. Not pregnant and willing to use adequate contraception for the duration of study participation; Exclusion (both groups) Requirements 1. Had or plan to receive any chemotherapy; 2. Have bilateral breast cancer 3. Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy; 4. Are pregnant or nursing; 5. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants; 6. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities; 7. Have received orthodontic work involving ferromagnetic materials; 8. Are claustrophobic; or 9. Medically unstable.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, San Francisco: collaborator
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (4)

Pacific Breast Care Medical Clinic

Costa Mesa, California, 92627, United States

Location

Beckman Laser Institute Medical Clinic

Irvine, California, 92612, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Helen Diller Family Comprehensive Cancer Center/ UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Breast Density

Intervention Hierarchy (Ancestors)

Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena

Study Officials

• Thomas O' Sullivan, PhD

  Beckman Laser Institute, UCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas O'Sullivan, Ph.D.Director, Diffuse Optical Spectroscopy & Imaging Laboratory

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 23, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

US (4)