NCT02310711

Multi-scale Modeling of Breast Conserving Therapy

A Pilot Study for the Identification of Targets for Clinical Improvement in Breast Conserving Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.

Detailed description

This is a single-center, prospective, pilot observation study. Eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. Data from the medical history will be recorded. As standard of care, the surgery will be scheduled and performed. Following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. The pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. The participant's role in the study will be completed after the week 24 visit.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Standard of Care	Standard of care for early stage breast cancer is breast conserving therapy at this center. Other concomitant standard of care treatment • Radiation therapy to the whole breast o 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions

Timeline

• Start date: 2012-05-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2014-12-08
• Last updated: 2018-10-10

Locations

1 site across 1 country: United States