Head and Neck CancerPhase 2MAGNOLIANCT04842162
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
A Phase 2 study testing indocyanine green in people with Head and Neck Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in 2 countries.
Trial summary
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2020to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female 18 years of age or older
- ECOG performance status 0-2
- Histological confirmation of squamous cell carcinoma
- Locating the primary tumour in the oral cavity or oropharynx
- Disease operable for complete resection
- Serum or urinary pregnancy test (as per centre practices) negative within 14 days prior to systemic indocyanin green injection (pre-operative visit), for women of childbearing age
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- Patient information and signed free and informed consent
- Patient affiliated with a social security scheme or beneficiary of a similar scheme.
- The patient must understand, sign and date the consent form prior to any protocol-specific procedures. The patient must be able and willing to comply with the study visits and procedures described in the protocol
Who cannot join
- Severe medical co-morbidities or contraindications to surgery
- Primary tumour not operable
- History of head and neck cancer in the past 5 years
- History of radiation for head and neck cancer
- Metastatic cancer
- Tumours with necrosis ranges in pre-operative imaging
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- History of invasive cancer unless there has been no recurrence for more than 5 years with an exception for non-melanoma skin cancers.
- Pregnant or nursing woman
- Allergy or hypersensitivity to the product being administered (its active substance or other ingredients), iodized products or crustaceans.
- Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular goiter of autoimmune origin.
- Documented coronary artery disease
- Advanced renal failure (creatinine > 1.5mg/dL).
- Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin).
- Patient under guardianship or curatorship or deprived of liberty by judicial or administrative decision or patient unable to give consent.
- Patients unable to undergo medical follow-up of the trial
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
Antoine DIGONNET
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94800
Philippe Gorphe, MD, +33 (0)1 42 11 42 11, philippe.gorphe@gustaveroussy.fr
Thibaud Motreff, +33 (0)1 42 11 42 11, thibaud.motreff@gustaveroussy.fr
About this study
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
- Conditions
- Head and Neck Cancer
- Being tested
- indocyanine green
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine greenDrug
indocyanine green (INFRACYANINE© 25mg/10mL).
| Study group | Role | What they receive |
|---|---|---|
| Patients with head and neck cancer | 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 Near Infrared Fluorescence Imaging
Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection.
For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N.
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Dec 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized bicentric study
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842162
- Sponsor's protocol ID
- 2019-002442-20
- Other IDs
- 2019/2886, 2019
- Acronym
- MAGNOLIA
- Status last verified
- Nov 2025
- First submitted
- 8 Apr 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
- ClinicalTrials.gov ID
- NCT04842162
- Acronym / sponsor ID
- MAGNOLIA / 2019-002442-20
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Apr 2021 (actual)
- 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.
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized bicentric study
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck cancer | 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 (9 listed)
- Male or female 18 years of age or older
- ECOG performance status 0-2
- Histological confirmation of squamous cell carcinoma
- Locating the primary tumour in the oral cavity or oropharynx
- Disease operable for complete resection
Key exclusion criteria (15 listed)
- Severe medical co-morbidities or contraindications to surgery
- Primary tumour not operable
- History of head and neck cancer in the past 5 years
- History of radiation for head and neck cancer
- Metastatic cancer
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 greenindocyanine green (INFRACYANINE© 25mg/10mL). | Drug | Patients with head and neck cancer |
Primary outcome
Sensitivity of Near Infrared Fluorescence Imaging
Time frame: at surgery
Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indocyanine green in people with Head and Neck Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in 2 countries.
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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Gorphe, MD (+33 (0)1 42 11 42 11, philippe.gorphe@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Near Infrared Fluorescence Imaging (time frame: at surgery). 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 26 Nov 2025.