Multi-scale Modeling of Breast Conserving Therapy (BCT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Standard of Care

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hopsital
      • Contact: Linda W Moore; Phone Number: 713-441-6144; Email: lwmoore@houstonmethodist.org
      • Principal Investigator: Barbara Bass, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.

Description

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Endpoint	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.	Six-month Post-Surgery

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Barbara Bass, MD, Chair, Department of Sugery

Publications and helpful links

General Publications

• Salmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Mastectomy; Breast; Lumpectomy; Breast Therapy
• Other Study ID Numbers: Pro00006887; IRB0112-0007 (Other Identifier: TMHRI IRB); BCTMM01 (Other Identifier: Other Protocol ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan to share data to be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No