Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer (NCT01614184) | Clinical Trial Compass
WithdrawnPhase 1/2
Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer
0Started 2008-05
Plain-language summary
The study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female patient
* Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
* Between 18 and 90 years of age.
* Have been diagnosed with invasive adenocarcinoma, or high-grade ductal carcinoma in-situ. If a core or open biopsy is done, it must demonstrate invasive adenocarcinoma. If only a FNA is done, it must be positive and accompanied by a positive clinical breast examination and ultrasound or mammography. The tumor must be operable.
* Clinically negative lymph nodes.
* Must have had a bilateral mammogram within a year of enrollment.
* The interval between the initial cytologic or histologic diagnosis of breast cancer and enrollment must be no more than 60 days.
* ECOG performance status 0-1
* Patients in whom the diagnosis of breast cancer has been obtained utilizing fine needle aspiration cytology or core needle biopsy are preferred. However, patients who are diagnosed by open biopsy procedures are eligible.
* Patients with prior excisional biopsy or lumpectomy are eligible for entry.
* Patients with prior non-breast malignancies are eligible if they have been disease free for 5 years before enrollment. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by operation only, or LCIS of the ipsilateral or contralateral breast treated by surgery only are eligible, even if these conditio…