Cavity Marking Technique for Breast Cancer

Overseen By Lauren Cox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Pregnancy, Breastfeeding, Prior breast surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to mark the area where a breast tumor was removed, aiming to improve the precision of subsequent radiation therapy. The technique helps identify the surgery area more accurately, particularly for those who might need additional surgery if cancer margins are too close or positive. Suitable candidates for this trial include individuals planning to undergo breast-conserving surgery and oncoplastic reconstruction for breast cancer. Participants should have a confirmed diagnosis of non-invasive ductal carcinoma in-situ or invasive breast cancer. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future breast cancer treatments.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cavity marking technique is safe for breast cancer patients?

Research has shown that using a marker to identify the surgical area can make radiation treatment more precise. One study found that this technique reduced treatment areas by about 50% compared to standard methods, potentially leading to fewer side effects from unnecessary radiation.

Although detailed safety data on this new marking technique is not yet available, its ability to make radiation more targeted is promising. Generally, methods that enhance precision in surgery and radiation are considered safe because they focus on the intended treatment area and reduce exposure to healthy tissue.

As a new technique, it has not been widely tested yet. However, the aim to improve surgery and radiation outcomes suggests potential safety benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The novel cavity marking technique for breast cancer is generating excitement because it aims to improve the precision of breast conservation surgery. Unlike current methods that can sometimes result in unclear surgical margins, this technique is designed to better define the area from which the tumor has been removed, making it easier for surgeons to achieve clear margins. This could potentially reduce the need for additional surgeries and preserve more healthy tissue, leading to better cosmetic outcomes and reduced recovery times. Researchers are eager to see if this approach can enhance surgical accuracy and overall patient satisfaction.

What evidence suggests that this cavity marking technique is effective for breast cancer?

Research has shown that breast-conserving surgery (BCS) effectively treats breast cancer while preserving the breast's appearance. In this trial, a novel cavity marking technique will be used during breast conservation surgery with oncoplastic reconstruction. This new method for marking the surgery site has been tested in 65 patients and appears promising. It helps doctors identify the edges of the surgical area more accurately, which is crucial for more precise radiation therapy and potentially improved patient outcomes. Currently, titanium clips often mark these areas, but the new technique aims for greater accuracy. The increased use of oncoplastic surgery has proven safe and effective for patients requiring tissue rearrangement after tumor removal. ^{3 6 7 8 9}

Who Is on the Research Team?

Lisa Spiguel, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals with non-invasive ductal carcinoma in-situ (DCIS) or invasive breast cancer at an early to intermediate stage, who are planning oncoplastic surgery. Participants must be relatively healthy (ECOG 0-1), have only one active cancer, and if of childbearing potential, use contraception during the study.

Inclusion Criteria

I have signed the consent form and agree to follow the study rules.

My breast cancer diagnosis ranges from non-invasive to invasive, but it hasn't spread beyond my lymph nodes.

I plan to have breast-saving surgery with reconstructive techniques.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo breast conservation surgery with oncoplastic reconstruction and novel cavity marking technique

1 day

1 visit (in-person)

Radiotherapy Planning and Delivery

Radiation oncology uses the novel cavity marking schema for CT simulation and radiotherapy planning and delivery

8 weeks

Follow-up

Participants are monitored for recurrence-free and overall survival, and local disease recurrence

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Novel cavity marking technique

Trial Overview The study tests a new way to mark the edges of the surgical area after tumor removal in breast conservation surgery. This aims to improve radiation therapy targeting post-surgery and identify margins more accurately for patients needing additional surgery.

How Is the Trial Designed?

Group I: Novel cavity marking technique during breast conservation surgery with oncoplastic reconstruction Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8931390/

An Innovative Breast-Conserving Oncoplastic Technique for ... Breast-conserving surgery (BCS) is considered an effective treatment means to cure tumors while maintaining a relatively satisfying appearance ( ...

2. ascopubs.org ascopubs.org/doi/10.1200/jco.2014.32.26_suppl.81

Identifying the surgical cavity following oncoplastic breast ... In this series of patients, a novel method for marking the surgical site when using oncoplastic techniques was evaluated. Methods: 65 patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452109421002062

Review of Current Accepted Practices in Identification ... Currently, a common practice for tumor cavity localization is applying titanium surgical clips to the borders of lumpectomy cavity.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6911616/

Increasing Role of Oncoplastic Surgery for Breast Cancer - PMC The increased use of OPS has generated data to validate safety and efficacy for tissue rearrangement techniques after partial mastectomy.

5. breastsurgeonsweb.com breastsurgeonsweb.com/wp-content/uploads/downloads/2012/10/515.pdf

Improving Breast Cancer Surgery: A Classification and ... Breast conservation surgery (BCS) combined with post- operative radiotherapy has become the preferred locoregional treatment for the majority of patients with.

6. ufhealth.org ufhealth.org/clinical-trials/cavity-marking-for-oncoplastic-reconstruction

Cavity marking for oncoplastic reconstruction This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093003/

A clinical perspective on oncoplastic breast conserving surgery The re-excision rate for OPBCS compared to s-BCS was lower [risk ratio (RR) 0.76; 95% confidence interval (CI): 0.69–0.85]. In line with these results, the OPBC ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0960977613000143

A new level 1 oncoplastic technique for breast conserving ... The wider the excision, the higher the risk of a poor cosmetic outcome, and hence breast deformity. Postoperative deformities after BCS and radiotherapy are ...

9. advancesradonc.org advancesradonc.org/article/S2452-1094(21)00206-2/pdf

Review of Current Accepted Practices in Identification of ... To provide an in-depth overview of current methods used to mark the tumor cavity for improved delineation as well as address the respective shortcomings in each ...