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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.