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Clinical Trials/NCT01614184
NCT01614184
Withdrawn
Phase 1

Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Operable Breast Cancer

University of Utah0 sitesMay 2008
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ConditionsBreast Cancer
InterventionsFluorescein
DrugsFluorescein

Overview

Phase
Phase 1
Intervention
Fluorescein
Conditions
Breast Cancer
Sponsor
University of Utah
Primary Endpoint
Sentinel Lymph node (SLN) detection
Status
Withdrawn
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • •Male patient
  • •Ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these latter to conditions are eligible.)
  • •One or more ipsilateral axillary lymph nodes that are positive for tumor on clinical examination.
  • •Bilateral malignancy or a mass in the opposite breast that is suspicious for malignancy, unless a biopsy proves that the mass is not malignant.
  • •Previous removal of any ipsilateral axillary lymph node.
  • •Diffuse tumors or multiple malignant tumors in different quadrants of the breast.
  • •Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.
  • •Patients with any prior breast malignancy other than LCIS.
  • •Prior treatment for this breast cancer including irradiation, chemotherapy, immunotherapy, and/or hormonal therapy.
  • •Allergy to radiocolloid or fluorescein.

Arms & Interventions

All patients

All patients enrolled in study.

Intervention: Fluorescein

Outcomes

Primary Outcomes

Sentinel Lymph node (SLN) detection

Time Frame: 36 months

Ability of peri-areolar or peri-tumoral fluorescein to detect SLNs in patients with operable breast cancer.

Secondary Outcomes

  • Correlation between two radiation intensities(36 months)
  • Fluorescence detection(36 months)
  • Number of patients with adverse events(36 months)
  • Fluorescence detection after processing(36 months)
  • Correlation between intensity and metastasis(36 months)

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