Back to Breast Cancer

NCT05545150

NCT05545150
Active, Not Recruiting Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are a woman aged 18 or older who has been diagnosed with invasive breast cancer and/or a non-invasive breast condition called ductal carcinoma in situ (DCIS)
  • You are planning to have breast-conserving surgery (a lumpectomy or partial mastectomy, where only part of the breast is removed, not the whole breast)
  • Your cancer or abnormal cells have been confirmed through a tissue sample (biopsy)
  • Your breast lesion has been seen on at least one type of imaging scan, such as a mammogram, ultrasound, or MRI
  • You are able to have a locating device placed to help guide the surgeon, along with imaging used during the operation
  • You (or your legal representative) are able to understand and sign a consent form before joining the study
  • You have had chemotherapy before surgery (neoadjuvant chemotherapy) — you are still eligible
  • You have cancer in both breasts or in more than one area of the same breast — you are still eligible (though the study device will only be used on one lesion)
  • You have had or currently have another type of cancer that is unlikely to affect this study's safety or results — you may still be eligible (confirm with trial site)

Who may not be able to join:

  • You are having a repeat surgery to remove remaining cancer cells from a previous breast operation (re-excision)
  • The piece of tissue expected to be removed during surgery is larger than approximately 9 cm x 9 cm x 7 cm (roughly the size of a small grapefruit), as this exceeds the limit for the study device
  • You have a physical health condition, mental health condition, or personal situation that the study doctor believes could affect your safety or your ability to fully participate in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Northwestern University
Registry
clinicaltrials_gov
Start date
28 November 2022
Est. completion
26 July 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Positive margins

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov