Breast CarcinomaPhase 3GASVERTNCT02997553
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
A Phase 3 study testing Indocyanine green, Technetium99 and Optonuclear probe in people with Breast Carcinoma and Head and Neck Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin)
- What is being tested?
- Indocyanine green, Technetium99 and Optonuclear probe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2017to 12 Oct 2022
- Phase
- Phase 3
- 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
- age >18 years
- cancer histologically proved
- patient eligible for sentinel node detection
- contraceptive methods for men and women of childbearing age
- signed informed consent form
- patient affiliated to the social security system
Who cannot join
- neoadjuvant chemotherapy or hormone therapy
- adenopathy (s) clinically suspicious or positively cytopenic
- women who are pregnant or breast-feeding
- associated pathology that may prevent patient of receive indocyanine green
- ongoing participation in another clinical trial with an investigational drug
- patients deprived of liberty or under supervision
- impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.
The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
- Conditions
- Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin), Squamous Cell Carcinoma, Skin, Cervix Cancer, Endometrium Cancer
- Being tested
- Indocyanine green, Technetium99, Optonuclear probe, Quest Camera
- Keywords
- Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, Surgery
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Melanoma, Carcinoma, Squamous Cell, Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called Infracyanine
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Technetium99Drug
Also called NANOCIS
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
Lymphoscintigraphy is performed to identify the sentinel node
Optonuclear probeDevice
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
Quest CameraDevice
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
| Study group | Role | What they receive |
|---|---|---|
| sentinel lymph node detection | Experimental | Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery. Receives: Drug: Indocyanine green; Drug: Technetium99; Device: Optonuclear probe; Device: Quest Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively.
Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
Measured: 1 day
Secondary outcomes (5)
Total number of sentinel lymph node detected
The total number of sentinel node detected will be assess by the two techniques
Measured: 1 day
Number of false negative result
False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node
Measured: 1 day
Allergic reactions
Percentage of patients with allergic reactions
Measured: 8 days
Evaluation of pain
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
Measured: 1 day
fluorescence imaging
The total number of sentinel node detected by fluorescence imaging
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start29 Nov 2017
- Primary completion19 Sep 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCHAL FREDERIC, MD, PU-PH, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997553
- Sponsor's protocol ID
- 2016-A00799-42
- Acronym
- GASVERT
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2016
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
- ClinicalTrials.gov ID
- NCT02997553
- Acronym / sponsor ID
- GASVERT / 2016-A00799-42
- Conditions
- Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin), Squamous Cell Carcinoma, Skin, Cervix Cancer, Endometrium Cancer
- Keywords
- Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 20 Dec 2016 (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.
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.
The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel lymph node detection | Experimental | Drug: Indocyanine green, Drug: Technetium99, Device: Optonuclear probe, Device: Quest CameraEach patient receive both injections of Technetium99 (standard care) and indocyanine green. The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >18 years
- cancer histologically proved
- patient eligible for sentinel node detection
- contraceptive methods for men and women of childbearing age
- signed informed consent form
Key exclusion criteria (7 listed)
- neoadjuvant chemotherapy or hormone therapy
- adenopathy (s) clinically suspicious or positively cytopenic
- women who are pregnant or breast-feeding
- associated pathology that may prevent patient of receive indocyanine green
- ongoing participation in another clinical trial with an investigational drug
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: InfracyanineEach patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use) | Drug | sentinel lymph node detection |
| Technetium99Also: NANOCISEach patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node | Drug | sentinel lymph node detection |
| Optonuclear probeThe detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery. | Device | sentinel lymph node detection |
| Quest CameraThe detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery. | Device | sentinel lymph node detection |
Primary outcome
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
Time frame: 1 day
The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
5 secondary outcomes
Total number of sentinel lymph node detected
Time frame: 1 day
Number of false negative result
Time frame: 1 day
Allergic reactions
Time frame: 8 days
Evaluation of pain
Time frame: 1 day
fluorescence imaging
Time frame: 1 day
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
MARCHAL FREDERIC, MD, PU-PH principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indocyanine green, Technetium99 and Optonuclear probe in people with Breast Carcinoma and Head and Neck Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 6 inclusion and 7 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 1 Sep 2026. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Non-inferiority of indocyanine green guided sentinel lymph node biopsy (time frame: 1 day). 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 1 Sep 2026.