Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer

NCT01614184 | Withdrawn Phase 1 DMC

• 1 other identifier: HCI23922
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Sentinel Lymph node (SLN) detection

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

  36 months

Secondary Outcomes (5)

• Fluorescence detection

  36 months

• Correlation between two radiation intensities

  36 months

• Correlation between intensity and metastasis

  36 months

• Fluorescence detection after processing

  36 months

• Number of patients with adverse events

  36 months

Study Arms (1)

All patients

EXPERIMENTAL

All patients enrolled in study.

Drug: Fluorescein

Interventions

Fluorescein DRUG

Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen.

Also known as: Fluorescite®

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 conditions were diagnosed within 5 years before enrollment onto this study.

You may not qualify if:

• 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.
• Inability to localize SLN drainage basins via lymphatic mapping. (e.g., no basin found which emits gamma-radiation after injection with technetium -99)
• Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol, or be exacerbated by therapy.
• Breast cancer related operative procedures not corresponding to criteria described in the protocol.
• Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
• History of organ transplantation.

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: June 7, 2012
• Study Start: May 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-07