Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06903468

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

Led by University of Florida · Updated on 2025-12-15

50

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 63 18 years of age.
  • Pathological diagnosis of non-invasive ductal carcinoma in-situ (DCIS) or invasive breast cancer, Tis-T3N0-3M0.
  • Planning to undergo or have undergone breast conservation surgery with oncoplastic reconstruction and cavity marking.
  • ECOG Performance status of 0-1.
  • Written informed consent provided and agreement to comply with study procedures.
  • No more than one active malignancy at enrollment (exceptions possible if approved).
  • Subjects of childbearing potential must use adequate contraception during surgery and radiation therapy and be informed of pregnancy risks.
Not Eligible

You will not qualify if you...

  • Patient not recommended for or has declined adjuvant radiotherapy.
  • Prior ipsilateral breast surgery with identifiable surgical clips.
  • Confirmed pregnancy or breastfeeding.
  • Any other disease or condition that contraindicates study treatment or risks complications, as judged by the treating physician.
  • Prisoners, involuntarily incarcerated individuals, or those compulsorily detained for psychiatric or physical illness.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

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Research Team

S

Stephanie Portillo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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