Head and Neck CancerSALVADS-FluoNCT02920216
Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
A study testing indocyanine green in people with Head and Neck Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck 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 siteFrance
- Study dates
- 6 Dec 2016to 6 Sep 2017
- 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
- Patient over 18 years old
- Head and Neck Squamous Cell Carcinoma confirmed by biopsy
- Non metastatic disease
- Resectable tumour
- Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy
- Haematological constants, liver function and kidney function adapted in the 15 days before inclusion:
Show all 17Show fewer
- Haemoglobin ≥ 9 g / dL
- Polymorphonuclear neutrophils ≥ 1.5 x 10 9
- Platelet ≥ 100 x 109 / L
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST <3 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Serum creatinine <110 mmol / L or creatinine clearance> 55 ml / min (method of Cockcroft)
- Absence of proteinuria
- WHO 0 or 1
- Signed informed consent form
- Patient affiliated to the social security system.
Who cannot join
- Patient considered as non eligible for a salvage surgery
- Metastatic disease
- Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.
Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.
Read more
The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.
The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.
- Conditions
- Head and Neck Cancer
- Being tested
- indocyanine green
- Keywords
- Head and Neck Neoplasms, Recurrence, Indocyanine Green, Salvage surgery
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine greenDrug
intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.
| Study group | Role | What they receive |
|---|---|---|
| eligible patient for a salvage surgery | Experimental | Not described Receives: Drug: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of indocyanine green labeling in Irradiated Area
The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.
Measured: 1 day
Secondary outcomes (1)
Sensitivity of indocyanine green labeling on surgical margins
The indocyanine green labeling on surgical margins will be compared to the surgical margins histological result
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 posted30 Sep 2016 (estimated)
- Study start6 Dec 2016
- Primary completion10 Aug 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CORTESE Sophie, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920216
- Sponsor's protocol ID
- 2016-A00014-47
- Acronym
- SALVADS-Fluo
- Status last verified
- Mar 2022
- First submitted
- 21 Sep 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cortese S, Kerrien E, Yakavets I, Meilender R, Mastronicola R, Renard S, Leroux A, Bezdetnaya L, Dolivet G. ICG-induced NIR fluorescence mapping in patients with head & neck tumors after the previous radiotherapy. Photodiagnosis Photodyn Ther. 2020 Sep;31:101838. doi: 10.1016/j.pdpdt.2020.101838. Epub 2020 May 30.
PubMed 32479902
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
- ClinicalTrials.gov ID
- NCT02920216
- Acronym / sponsor ID
- SALVADS-Fluo / 2016-A00014-47
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Neoplasms, Recurrence, Indocyanine Green, Salvage surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 30 Sep 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.
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.
Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.
The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.
The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eligible patient for a salvage surgery | Experimental | Drug: indocyanine green |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient over 18 years old
- Head and Neck Squamous Cell Carcinoma confirmed by biopsy
- Non metastatic disease
- Resectable tumour
- Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy
Key exclusion criteria (4 listed)
- Patient considered as non eligible for a salvage surgery
- Metastatic disease
- Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
- Pregnant or breastfeeding women
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 greenintravenous injection of Indocyanine Green (0,25mg/kg) before surgery. | Drug | eligible patient for a salvage surgery |
Primary outcome
Sensitivity of indocyanine green labeling in Irradiated Area
Time frame: 1 day
The indocyanine green labeling in irradiated areas will be compared to the histological result on the surgical specimen.
1 secondary outcome
Sensitivity of indocyanine green labeling on surgical margins
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 31 Mar 2022.
- Background: PubMed 32479902Cortese S, Kerrien E, Yakavets I, Meilender R, Mastronicola R, Renard S, Leroux A, Bezdetnaya L, Dolivet G. ICG-induced NIR fluorescence mapping in patients with head & neck tumors after the previous radiotherapy. Photodiagnosis Photodyn Ther. 2020 Sep;31:101838. doi: 10.1016/j.pdpdt.2020.101838. Epub 2020 May 30.
- 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.
CORTESE Sophie, MD 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 study testing indocyanine green in people with 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 17 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: finished, as of the sponsor's last update on 31 Mar 2022. 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.
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?
Sensitivity of indocyanine green labeling in Irradiated Area (time frame: 1 day). 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 NCT02920216, which also lists 1 linked publication.
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 31 Mar 2022.