Malignant Neoplasm of BreastPhase 2NCT01395706
ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes
A Phase 2 study testing ICG Fluorescence technique in people with Malignant Neoplasm of Breast, run by Pulsion Medical Systems SE at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- ICG Fluorescence technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Diethelm Wallwiener, Prof. Dr. contact
Germany1 site
University Department of Gynecology and Obstetrics
Tübingen, 72076
About this study
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
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.
Read the 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.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- ICG Fluorescence technique
- Keywords
- Malignant Neoplasm of Breast, Sentinel lymph node detection, ICG fluorescence technique, Population of male and female patients with mamma carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG Fluorescence techniqueProcedure or surgery
Also called Indocyanine Green (ICG)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ICG Fluorescence technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity using ICG
Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes
Measured: 5 to 11 days
Secondary outcomes (1)
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
Measured: 5 to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulsion Medical Systems SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Diethelm Wallwiener, Prof. Dr., Principal investigator, University Hospital Tuebingen, University Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395706
- Sponsor's protocol ID
- PULSION-001
- Status last verified
- Jul 2011
- First submitted
- 14 Jul 2011
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01395706
- Acronym / sponsor ID
- PULSION-001
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Pulsion Medical Systems SEIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG flourescence technique | Experimental | Procedure: ICG Fluorescence techniqueThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG Fluorescence techniqueAlso: Indocyanine Green (ICG)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 | Procedure or surgery | ICG flourescence technique |
Primary outcome
Sensitivity using ICG
Time frame: 5 to 11 days
Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes
1 secondary outcome
Specificity using ICG
Time frame: 5 to 11 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diethelm Wallwiener, Prof. Dr. contact
Diethelm Wallwiener, Prof. Dr. principal investigator
University Hospital Tuebingen, University Department of Gynecology and Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICG Fluorescence technique in people with Malignant Neoplasm of Breast, run by Pulsion Medical Systems SE at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diethelm Wallwiener, Prof. Dr. (++49-7071-29-82-0 ext. -246, Diethelm.Wallwiener@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity using ICG (time frame: 5 to 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.