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New treatment option for Ductal Carcinoma in Situ
Official title Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions
ClinicalTrials.gov ID: NCT06903468
What this study is testing
- What it's testing
- This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ 18 years of age.
- A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0
- Subject is planning to undergo or has undergone breast conservation surgery and oncoplastic reconstruction with cavity marking surgery.
- ECOG Performance status of 0-1
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
You likely can't join if
- Patient not recommended for, or have declined, adjuvant radiotherapy
- people with prior ipsilateral breast surgery and identifiable surgical clips.
- people who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detailed for treatment of either a psychiatric or physical...
See the full eligibility criteria
- Adults ≥ 18 years of age.
- A pathological diagnosis consistent with non-invasive ductal carcinoma in-situ (DCIS) and invasive breast cancer, Tis-T3N0-3M0
- Subject is planning to undergo or has undergone breast conservation surgery and oncoplastic reconstruction with cavity marking surgery.
- ECOG Performance status of 0-1
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- people must not have more than one active malignancy at the time of enrollment (people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or...
- people of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, people of childbearing potential must be...
- Patient not recommended for, or have declined, adjuvant radiotherapy
- people with prior ipsilateral breast surgery and identifiable surgical clips.
- people who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detailed for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.