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. 2013 Mar 17;20(8):2590–2599. doi: 10.1245/s10434-013-2887-8

Table 1.

Study enrollment criteria

Inclusion criteria
Confirmed presence of primary breast cancer
Candidate for surgical intervention, with lymph node mapping being part of the surgical plan
At least 18 years of age at time of consent
ECOG performance status of grade 0–2
If female, either negative pregnancy test within 72 h prior to [99mTc]tilmanocept administration, having been surgically sterilized, or postmenopausal for at least 1 year prior to start of study
Pure ductal carcinoma in situ (DCIS) or noninvasive carcinoma with lymph node biopsy as part of the surgical plan
Exclusion criteria
Pregnancy or lactation
Clinical or radiological evidence of metastatic cancer, including palpably abnormal or enlarged lymph nodes
Known hypersensitivity to Lymphazurin or patent blue V
Participation in another investigational drug study
Bilateral primary breast cancers or multiple breast tumors
Prior surgical breast surgery (e.g., axillary surgery, implants)
Scheduling for bilateral mastectomy if bilateral SLN mapping is required
Preoperative radiation therapy to the affected breast or axilla