Multi-scale Modeling of Breast Conserving Therapy

NCT ID: NCT02310711

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2020-08-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Barbara Bass

Chair, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Bass, MD

Role: PRINCIPAL_INVESTIGATOR

Chair, Department of Sugery

Locations

Houston Methodist Hopsital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Linda W. Moore

Role: CONTACT

lwmoore@houstonmethodist.org

713-441-6144

Facility Contacts

Linda W Moore

Role: primary

lwmoore@houstonmethodist.org

713-441-6144

References

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.

Reference Type: BACKGROUND

PMID: 25906048 (View on PubMed)

Other Identifiers

IRB0112-0007

Identifier Type: OTHER

Identifier Source: secondary_id

BCTMM01

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00006887

Identifier Type: -

Identifier Source: org_study_id