Breast Cancer Clinical Trial

Multi-scale Modeling of Breast Conserving Therapy

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT02310711

Recruitment Status:

Unknown status

Sponsor:

The Methodist Hospital Research Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Houston Methodist Hopsital
Houston Texas, 77030, United States More Info
Linda W Moore
Contact
713-441-6144
[email protected]
Barbara Bass, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT02310711

Recruitment Status:

Unknown status

Sponsor:


The Methodist Hospital Research Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider