RightFit
RecruitingPhase not listed

Intra-Operative Radiation Registry

Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol

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
Female only
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 tracks how well radiation given during breast surgery keeps cancer from coming back in the treated area. It also tracks side effects. It is for women who meet expert guidelines for radiation to only part of the breast.

This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.

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

Eligibility

Who can join

  • Women age 45 or older.
  • Either invasive breast cancer under 3.5 cm, stage cT1–2N0 (no signs of spread to nearby lymph nodes), that responds to estrogen; or DCIS as described below.
  • For DCIS (cancer inside the breast milk ducts): found on a mammogram, under 2.5 cm, grade 1–2 (low or medium grade), and responds to estrogen.
  • Able to have breast-saving surgery to remove the cancer (lumpectomy).
  • No medical reason that prevents radiation treatment.
  • Had a mammogram within 6 months before the planned procedure.
  • Healthy enough for lumpectomy under general anesthesia (medicine that keeps you asleep).
  • Plan to receive radiation during surgery (IORT).

Who can't join

  • Breast cancer known to have spread to lymph nodes in the armpit. A biopsy proving no spread is not required.
  • Cancer in separate areas of the same breast that cannot all be removed in one lumpectomy with cancer-free edges.
  • Known BRCA1 or BRCA2 gene changes.
  • Receiving chemotherapy before surgery.
  • Pregnant.

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

Official eligibility criteria

Inclusion Criteria: * Female gender * Age ≥ 45 * cT1-2N0, \<3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive * Suitable for breast conserving surgery * No contraindication to radiation * Mammogram within 6 months of planned procedure * Fitness for lumpectomy under general anesthesia * Planned to receive IORT Exclusion criteria * Known axillary lymph node positive breast cancer (negative biopsy not required) * Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy. * Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene * Patients undergoing neoadjuvant chemotherapy * Pregnancy

Study sites (1)

NY