Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT00671918
Eligibility Criteria:
Inclusion Criteria:
* The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.
* The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.
* The patient is at least 18 years of age at the time of consent.
* The patient has an ECOG performance status of Grade 0 - 2 \[8\].
* The patient has a clinical negative node status at the time of study entry.
* If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
* The patient is currently not participating in another investigational drug study.
Melanoma Patients
* The patient has a diagnosis of primary melanoma.
Breast Cancer Patients
* The patient has a diagnosis of primary breast cancer.
* Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.
Exclusion Criteria:
* The patient is pregnant or lactating;
* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);
* The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.
Melanoma Patients
* The patient has a tumor with a Breslow depth less than 0.75mm.;
* Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;
* Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;
* Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;
* Patients who have undergone a wide excision for their primary melanoma (\>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).
Breast Cancer Patients
* The patient has bilateral primary breast cancers or multiple tumors within their breast;
* Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;
* Patients scheduled for bilateral mastectomy for any reason;
* Patients that have had preoperative radiation therapy to the affected breast or axilla
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00671918
Study Brief:
Protocol Section:
NCT00671918