Multi-scale Modeling of Breast Conserving Therapy

• Conditions: Breast Cancer

• Registration Number: NCT02310711
• Lead Sponsor: The Methodist Hospital Research Institute

Brief 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-10
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Adult females ≥ age 30 years
2. Have early stage (Stage I, II), non-metastatic breast cancer
3. Planned to receive BCT
4. Have received a pre-operative mammogram within 30 days of surgery
5. Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
6. Planned to receive post-surgery radiotherapy by whole breast radiotherapy
7. Signed informed consent form prior to any research assessment

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Exclusion Criteria

1. Adult females younger than 30 years of age
2. Previous breast cancer
3. Neo-adjuvant therapy for breast cancer
4. Pregnant or nursing females
5. Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study Endpoint	Six-month Post-Surgery	The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.

Trial Locations

Locations (1)

Houston Methodist Hopsital; 🇺🇸 Houston, Texas, United States