RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new way to mark the edges of the space left after a breast tumor is removed. It is for adults with breast cancer who have surgery to save and reshape the breast. The marks may help doctors aim radiation more accurately and find tissue that needs to be removed in another surgery.

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. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have breast cancer confirmed by a tissue test: DCIS (cancer inside the milk ducts) or invasive breast cancer, within stages Tis–T3, N0–N3, M0. The cancer must not have spread to distant parts of the body.
  • Plan to have, or have already had, surgery to save and reshape the breast with marks placed around the space where the tumor was removed.
  • Are fully active or can do light work despite limits on hard physical activity.
  • Sign a consent form and agree to follow all study steps.
  • Have no more than one active cancer. Another past or current cancer may be allowed if the doctor or study leader decides it will not affect study safety or results.
  • If able to become pregnant, use effective birth control during surgery and radiation. Before joining, receive advice about avoiding pregnancy and the risks of an unplanned pregnancy.

Who can't join

  • Radiation after surgery is not recommended, or you have chosen not to have it.
  • Have had surgery on the same breast and have surgical clips that can be identified.
  • Are pregnant or breastfeeding.
  • Have another illness or test finding that your doctor thinks could make study treatment unsafe, affect the results, or raise your risk of treatment problems.
  • Are a prisoner, are held against your will, or are required to stay for treatment of a mental or physical illness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. * Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the PI\] may be included). * Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy during surgery and radiation therapy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during the surgery and radiation portions of the trial and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as amenorrhea that has lasted for ≥ 12 consecutive months without another cause. Exclusion Criteria: * Patient not recommended for, or have declined, adjuvant radiotherapy * Subjects with prior ipsilateral breast surgery and identifiable surgical clips. * Subjects 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 that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detailed for treatment of either a psychiatric or physical illness.

Study sites (1)

FL