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ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

Primary Purpose

Malignant Neoplasm of Breast

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

ICG Fluorescence technique

About this trial

This is an interventional diagnostic trial for Malignant Neoplasm of Breast focused on measuring Malignant Neoplasm of Breast, Sentinel lymph node detection, ICG fluorescence technique, Population of male and female patients with mamma carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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,
lifestyle with a personal choice of abstinence,
bilateral vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods
Willing and able to complete screening and study procedures, as described in the protocol
Signed written informed consent to participate in this clinical trial

Exclusion Criteria:

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
Evidence of local inflammation at the site of surgery
Concurrent medication or any medication during the 2 weeks preceeding the enrolment which reduce or increase the extinction of ICG (i.e. anticonvulsants, haloperidol)
Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol or drugs despite the development of social, legal, or health problems
Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements (e.g. Alzheimer's disease)
Pregnancy, breastfeeding
Inability to understand the nature and the extent of the trial and the procedures required
Missing signed written informed consent to participate in the clinical trial
Participation in a drug trial during the whole clinical trial

Sites / Locations

University Department of Gynecology and Obstetrics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG flourescence technique

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity using ICG

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

Secondary Outcome Measures

Specificity using ICG

Specificity using ICG: number of patients with fluorescent positive sentinel lymph nodes that are not tumour - involved / number of patients with Tc positive SLN False negative rate: Number of patients where no sentinel lymph node is detected with Tc but with ICG / total number of patients with at least one Tc positive SLN Detection rate for the SLN using the ICG fluorescence imaging method: number of patients with at least one fluorescent sentinel lymph node per total number of patients treated with ICG Safety and tolerability of the IMP

Full Information

NCT ID

NCT01395706

First Posted

July 14, 2011

Last Updated

July 15, 2011

Sponsor

Pulsion Medical Systems SE

1. Study Identification

Unique Protocol Identification Number

NCT01395706

Brief Title

ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

Official Title

Determination of the Sensitifity of ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes in Breast Cancer - a Monocenter Prospective Open-label Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Pulsion Medical Systems SE

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Considering the high diagnostic accuracy and less vulnerable staging and therapy procedures, SLNB has rapidly become the state of the art diagnostic for axillary staging in early breast cancer. Prior surgery, the so called sentinel lymph nodes are detected, harvested and histopathologically examined. The histopathologic status of the sentinel node thereby accurately reflects the status of the remaining axillary nodes. The sentinel lymph node biopsy allows minimizing risks and burdens for patients who very likely have no metastasis in the axillary lymph nodes sparing the ALND and reducing the risk of surgery and postoperative lymph oedema for instance. Contrarily to former procedure where an axillary lymph node dissection (ALND) was done each time, an ALND now only follows if the detected sentinel lymph node is metastatic. Routinely sentinel lymph nodes are mapped using radiocolloid tracers such as technetium, sometimes combined with a blue dye. However the infrastructure for a radioactive tracing is complex and not available easily: special techniques and equipment for the manufacturing of the radiocolloid as well as training in the use with radioisotopes are needed. For example, the application of radioactive markers needs a ready access to a nuclear medicine department, a pre-operative visit and an effective coordination between the involved disciplinesis. As these radioisotopes are formed by specialised, rare industry facilities availability is heavenly dependend and lack of radioisotopes with shortages in diagnostic procedures has already been reported. Furthermore radiocolloid mapping is associated with radioactive exposure of the concerned patients and health workers and imposes problems with surgical waste disposal. Novel methods for detecting sentinel lymph nodes which waive the pre-operative injection of the radioactive marker are currently investigated. One of these new methods is the application of a fluorescence marker for SLN detection. In this clinical trial a novel method for detecting the sentinel lymph node using indocyanine green, a fluorescent molecule shall by investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICG flourescence technique

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ICG Fluorescence technique

Other Intervention Name(s)

Indocyanine Green (ICG)

Intervention Description

Primary Outcome Measure Information:

Title

Sensitivity using ICG

Description

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

Time Frame

5 to 11 days

Secondary Outcome Measure Information:

Title

Specificity using ICG

Description

Time Frame

5 to 11 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, lifestyle with a personal choice of abstinence, bilateral vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods Willing and able to complete screening and study procedures, as described in the protocol Signed written informed consent to participate in this clinical trial Exclusion Criteria: 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 Evidence of local inflammation at the site of surgery Concurrent medication or any medication during the 2 weeks preceeding the enrolment which reduce or increase the extinction of ICG (i.e. anticonvulsants, haloperidol) Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol or drugs despite the development of social, legal, or health problems Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements (e.g. Alzheimer's disease) Pregnancy, breastfeeding Inability to understand the nature and the extent of the trial and the procedures required Missing signed written informed consent to participate in the clinical trial Participation in a drug trial during the whole clinical trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diethelm Wallwiener, Prof. Dr.

Phone

++49-7071-29-82-0

Ext

-246

Diethelm.Wallwiener@med.uni-tuebingen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diethelm Wallwiener, Prof. Dr.

Organizational Affiliation

University Hospital Tuebingen, University Department of Gynecology and Obstetrics

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Department of Gynecology and Obstetrics

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

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ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

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