Breast Cancer.Phase 1/2EC2075NCT01993576
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.
A Phase 1/2 study testing Indocyanine Green in people with Breast Cancer., run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer.
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 1/2
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
- Informed Consent signed.
Who cannot join
- Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
- Operation after neo-adjuvant chemotherapy,
- Age less than 18 years.
- For pre-menopausal women, an operation planned for the second phase of their cycle.
- Inability to give informed consent.
- History of allergy or hypersensitivity to the investigational product, iodine.
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- Clinical or biological hyperthyroidism.
- Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
- A reported pathological coronary artery disease.
- Creatinine > 1.5 mg / dl.
- During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).
- Pregnancy or breast feeding period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
Read the detailed description
Primary objective:
Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).
Secondary objectives:
Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.
Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).
- Conditions
- Breast Cancer.
- Being tested
- Indocyanine Green
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
| Study group | Role | What they receive |
|---|---|---|
| indocyanine green | Experimental | Indocyanine green is injected intravenously. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.
Measured: 10 months
Secondary outcomes (1)
Microscopical detection of indocyanine green in breast tissue.
Detecting the fluorescence in between benign and malignant tissue by a microscope with a filter for near ifra-red at a good wave length of ICG.
Measured: 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer.Studies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Nogaret, Prof., Study chair, Jules Bordet InstituteIsabelle Veys, MD, Study chair, Jules Bordet InstituteSophie VanKerckhove, biologist, Study chair, Jules Bordet InstitutePhilippe De Neubourg, MD, Study chair, Jules Bordet InstituteDanielle Noterman, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993576
- Sponsor's protocol ID
- 2013-000100-41
- Acronym
- EC2075
- Status last verified
- Jul 2014
- First submitted
- 6 May 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
- ClinicalTrials.gov ID
- NCT01993576
- Acronym / sponsor ID
- EC2075 / 2013-000100-41
- Conditions
- Breast Cancer.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Nov 2013 (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.
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
Detailed description
Primary objective:
Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).
Secondary objectives:
Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.
Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| indocyanine green | Experimental | Drug: Indocyanine GreenIndocyanine green is injected intravenously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
- Informed Consent signed.
Key exclusion criteria (12 listed)
- Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
- Operation after neo-adjuvant chemotherapy,
- Age less than 18 years.
- For pre-menopausal women, an operation planned for the second phase of their cycle.
- Inability to give informed consent.
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGIntravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery | Drug | indocyanine green |
Primary outcome
Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
Time frame: 10 months
Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.
1 secondary outcome
Microscopical detection of indocyanine green in breast tissue.
Time frame: 10 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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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.
Jean-Marie Nogaret, Prof. study chair
Jules Bordet Institute
Isabelle Veys, MD study chair
Jules Bordet Institute
Sophie VanKerckhove, biologist study chair
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Indocyanine Green in people with Breast Cancer., run by Jules Bordet Institute at 1 site in Belgium.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 15 Oct 2014. 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 Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma. (time frame: 10 months). 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 15 Oct 2014.