Multi-scale Modeling of Breast Conserving Therapy

Status unconfirmed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02310711

Run by

The Methodist Hospital Research Institute

People needed

15

Starts

2012-05-01

Expected to finish

2020-08-01

Last updated by the study team

2018-10-10

Who can join

Age: 30 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Houston Methodist Hopsital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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