MelanomaNCT02142244
Fluorescence Surgery for Sentinel Node Identification in Melanoma
A study testing Near infra red sentinel node biopsy, Indocyanine green and Intraoperative Near-Infrared Imaging System in people with Melanoma and Lymph Node Metastasis, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Lymph Node Metastasis
- What is being tested?
- Near infra red sentinel node biopsy, Indocyanine green and Intraoperative Near-Infrared Imaging System
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for sentinel node biopsy in standard care
Who cannot join
- Previous neoplasia
- Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
- Local recurrence
- Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784400
Camila Crovador, +551733216600 ext. 6938, camila.nap@hcancerbarretos.com.br
Vinicius L Vazquez, Ph.D., +551733216600 ext. 6938, viniciusvazquez@gmail.com
About this study
Official title: Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.
Read the detailed description
The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.
- Conditions
- Melanoma, Lymph Node Metastasis
- Being tested
- Near infra red sentinel node biopsy, Indocyanine green, Intraoperative Near-Infrared Imaging System
- Keywords
- Sentinel node biopsy, Near infra red light, Indocyanine green, micrometastasis
- Medical subject headings
- Melanoma, Lymphatic Metastasis, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infra red sentinel node biopsyProcedure or surgery
Also called Sentinel node biopsy with fluorescence
Explicated in the protocol arm
Indocyanine greenDrug
Explicated in the protocol arm
Intraoperative Near-Infrared Imaging SystemDevice
Also called Photodynamic Eye (PDE), Pulsion, MiniFlare, The Flare Foundation
Explicated in the protocol arm
| Study group | Role | What they receive |
|---|---|---|
| Near infra red sentinel node biopsy | Experimental | Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy. Receives: Procedure: Near infra red sentinel node biopsy; Drug: Indocyanine green; Device: Intraoperative Near-Infrared Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of the sentinel node biopsy
The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed
Measured: Time of surgery
Secondary outcomes (1)
Specificity of the sentinel node biopsy
The false negative sentinel node biopsy rate. The proportion of patients submitted to the procedure with histological negative biopsy, presenting lymph node metastasis at follow up.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinicius L Vazquez, Ph.D., Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142244
- Sponsor's protocol ID
- BCHNIR01
- Status last verified
- Sep 2016
- First submitted
- 9 May 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tanaka E, Choi HS, Fujii H, Bawendi MG, Frangioni JV. Image-guided oncologic surgery using invisible light: completed pre-clinical development for sentinel lymph node mapping. Ann Surg Oncol. 2006 Dec;13(12):1671-81. doi: 10.1245/s10434-006-9194-6. Epub 2006 Sep 29.
PubMed 17009138Frangioni JV. New technologies for human cancer imaging. J Clin Oncol. 2008 Aug 20;26(24):4012-21. doi: 10.1200/JCO.2007.14.3065.
PubMed 18711192Namikawa K, Yamazaki N. Sentinel lymph node biopsy guided by indocyanine green fluorescence for cutaneous melanoma. Eur J Dermatol. 2011 Mar-Apr;21(2):184-90. doi: 10.1684/ejd.2010.1237.
PubMed 21498148van der Vorst JR, Schaafsma BE, Verbeek FP, Swijnenburg RJ, Hutteman M, Liefers GJ, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Dose optimization for near-infrared fluorescence sentinel lymph node mapping in patients with melanoma. Br J Dermatol. 2013 Jan;168(1):93-8. doi: 10.1111/bjd.12059.
PubMed 23078649
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT02142244
- Acronym / sponsor ID
- BCHNIR01
- Conditions
- Melanoma, Lymph Node Metastasis
- Keywords
- Sentinel node biopsy, Near infra red light, Indocyanine green, micrometastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 May 2014 (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.
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.
Detailed description
The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near infra red sentinel node biopsy | Experimental | Procedure: Near infra red sentinel node biopsy, Drug: Indocyanine green, Device: Intraoperative Near-Infrared Imaging SystemSentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for sentinel node biopsy in standard care
Key exclusion criteria (4 listed)
- Previous neoplasia
- Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
- Local recurrence
- Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
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 |
|---|---|---|
| Near infra red sentinel node biopsyAlso: Sentinel node biopsy with fluorescenceExplicated in the protocol arm | Procedure or surgery | Near infra red sentinel node biopsy |
| Indocyanine greenExplicated in the protocol arm | Drug | Near infra red sentinel node biopsy |
| Intraoperative Near-Infrared Imaging SystemAlso: Photodynamic Eye (PDE), Pulsion, MiniFlare, The Flare FoundationExplicated in the protocol arm | Device | Near infra red sentinel node biopsy |
Primary outcome
Sensibility of the sentinel node biopsy
Time frame: Time of surgery
The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed
1 secondary outcome
Specificity of the sentinel node biopsy
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Background: PubMed 17009138Tanaka E, Choi HS, Fujii H, Bawendi MG, Frangioni JV. Image-guided oncologic surgery using invisible light: completed pre-clinical development for sentinel lymph node mapping. Ann Surg Oncol. 2006 Dec;13(12):1671-81. doi: 10.1245/s10434-006-9194-6. Epub 2006 Sep 29.
- Background: PubMed 18711192Frangioni JV. New technologies for human cancer imaging. J Clin Oncol. 2008 Aug 20;26(24):4012-21. doi: 10.1200/JCO.2007.14.3065.
- Background: PubMed 21498148Namikawa K, Yamazaki N. Sentinel lymph node biopsy guided by indocyanine green fluorescence for cutaneous melanoma. Eur J Dermatol. 2011 Mar-Apr;21(2):184-90. doi: 10.1684/ejd.2010.1237.
- Background: PubMed 23078649van der Vorst JR, Schaafsma BE, Verbeek FP, Swijnenburg RJ, Hutteman M, Liefers GJ, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Dose optimization for near-infrared fluorescence sentinel lymph node mapping in patients with melanoma. Br J Dermatol. 2013 Jan;168(1):93-8. doi: 10.1111/bjd.12059.
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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.
Vinicius L Vazquez, Ph.D. principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infra red sentinel node biopsy, Indocyanine green and Intraoperative Near-Infrared Imaging System in people with Melanoma and Lymph Node Metastasis, run by Barretos Cancer Hospital at 1 site in Brazil.
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 1 inclusion and 4 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 2 Feb 2017. 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 Brazil. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility of the sentinel node biopsy (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02142244, which also lists 4 linked publications.
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 2 Feb 2017.