An interventional study of Sentinel node biopsy with blue dye and radioisotope in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
This study is for participants with inflammatory breast cancer (IBC). The purpose of this study is to find out whether it is possible to take a sample of underarm lymph nodes for participants with IBC. The participants will undergo sentinel lymph node biopsy (SLNB) in addition to full axillary lymph node dissection (ALND) during the planned breast cancer surgery. Participants enrolled in the study will first be injected with tracer, then undergo SLNB, and then undergo full ALND.
Inflammatory breast cancer is a rare and aggressive type of cancer where the tumor cells invade the lymphatic vessels in the skin. This causes the appearance of red and swollen breasts. Most participants are diagnosed with locally advanced disease, and the standard treatment is chemotherapy, followed by mastectomy and axillary lymph node dissection, radiation treatment, and then adjuvant therapy. But advances in therapy have called into question if mastectomy with ALND is still necessary in participants with IBC, with some physicians advocating for the option of sentinel lymph node biopsy. However, SLNB in participants with IBC has been met with mixed results.
Despite these mixed results, many physicians in the United Stares are still performing SLNB either using blue dyes or dual tracers. The purpose of this study is to find out the rate of identifying sentinel lymph nodes is participants with IBC , whether the sentinel lymph node status correlates with any more positive nodes, and the rates of complete response based on the subtype of IBC.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 493 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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Exclusion Criteria:
Participant is pregnant at the time of surgery
For participants diagnosed with IBC
Diagnostic Test: Sentinel node biopsy with blue dye and radioisotope
Participants will be injected with blue dye and radioisotope tracer into the breast of tumor that drains into the first axillary lymph nodes during their planned surgical procedure so that the sentinel lymph nodes can be sampled.
Rate of identification of sentinel lymph nodes
Rate of identification of sentinel lymph nodes in participants with IBC will be calculated by dividing the number of cases in which at least 1 sentinel lymph node is identified by the total number of patients in the study who underwent attempted sentinel lymph node biopsy.
Time frame: at day 1
Sentinel lymph node status
Examine whether sentinel lymph node status correlates with any additional positive nodes in axilla
Time frame: at day 1
Rates of pathologic complete response
Examine rates of pathologic complete response in the breast and axilla based on biological subtype of inflammatory breast cancer.
Time frame: at day 1
Plan to share: No — Sharing of IPD is necessary for this protocol
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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