ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

NCT01395706 | Unknown Phase 2 DMC

• 1 other identifier: PULSION-001
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of Clinical Trial The main objective of this clinical trial is to show the efficacy of fluorescence lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.

Conditions

Malignant Neoplasm of Breast

Keywords

Malignant Neoplasm of Breast; Sentinel lymph node detection; ICG fluorescence technique; Population of male and female patients with mamma carcinoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity using ICG

  Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes

  5 to 11 days

Secondary Outcomes (1)

• Specificity using ICG

  5 to 11 days

Study Arms (1)

ICG flourescence technique

EXPERIMENTAL

This is an uncontrolled, non-randomised, open-label, monocenter clinical trial. A total of n=125 subjects will participate in this clinical trial. No clinical trial participant will be allowed to be included in this trial more than once.

Procedure: ICG Fluorescence technique

Interventions

ICG Fluorescence technique PROCEDURE

This is an uncontrolled, non-randomised, open-label, monocenter clinical trial. A total of n=125 subjects will participate in this clinical trial. No clinical trial participant will be allowed to be included in this trial more than once. 10 mg (5mg/ml)per injection are applicated

Also known as: Indocyanine Green (ICG)

ICG flourescence technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early breast cancer: histopathologically confirmed diagnosis, maximum tumour stage T1 and T2, therefore diameter \< 5 cm, unifocal tumour or multifocal tumour Grading G1-G3, invasive ductal and / or invasive lobar carcinoma ≤ 5 cm diameter
• Indicated sentinel lymph node biopsy as part of the patient's routine management for breast cancer
• Age: 18 - 80 years, inclusive
• Gender: male and female
• BMI: ≤ 30
• Non-smoker (for at least the previous 3 months)
• General operability
• Intact site-specific anatomy at the concerned breast and /or axilla for ensuring an adequate lymphangiography
• Performance of investigations with radioactive traced iodide at least 1 week before and 1 week after ICG application
• No clinically significant findings in the routine blood examinations
• Female subjects with childbearing potential must have a negative pregnancy test prior Tc application and must be either at least two years postmenopausal or using a highly effective mean of birth control (birth control that, alone or in combination, result in a low failure rate of less than 1 percent per year when used consistently and correctly):
• hormonal method of contraception,
• surgical sterility,
• double barrier methods,
• intrauterine contraceptive device,

You may not qualify if:

• Breast cancer: stage T3 or T4 carcinoma, inflammatory or exulcerated mamma carcinoma
• Former operation in axilla
• Any previous radiotherapy at the concerned breast and / or axilla and / or chestwall
• Definite lymph node metastases (ultrasound and / or fine-needle aspiration) (definite nodal positive patients in fine-needle aspiration)
• Contraindication for technetium imaging
• History of allergy or hypersensitivity against the investigational medicinal products (its active substance or ingredients)
• History of intolerability to ICG-Pulsion during a previous injection, as this may lead to serious anaphylactic reactions
• History of allergic diseases / hypersensitivities, unless the investigator considers the allergic disease as clinically irrelevant for the purpose of this clinical trial
• Allergy to iodine or to shellfish
• Any other contraindication to one of the investigational medicinal products as described in their Summary of Product Characteristics
• Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland
• Advanced renal impairment (creatinine \> 1,5mg/dl)
• Complete lymphatic obstruction
• All clinically relevant internal medicinal diseases, cardiac or renal that could impair the outcome of the clinical trial or that in the investigator's mind are not compatible with participation for medical reasons
• Acute inflammatory or febrile illness

Sponsors & Collaborators

• Pulsion Medical Systems SE: lead

Study Sites (1)

University Department of Gynecology and Obstetrics

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Diethelm Wallwiener, Prof. Dr.

  University Hospital Tuebingen, University Department of Gynecology and Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diethelm Wallwiener, Prof. Dr.

CONTACT

++49-7071-29-82-0; Diethelm.Wallwiener@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 15, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

DE (1)