Study evaluating near-infrared imaging coupled with indocyanine green for intraoperative monitoring of resection margins in ENT surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Gustave Roussy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

15 Dec 2020 → ongoing

Decision date (initial)

2023-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gustave roussy

External identifiers

EU CT number

2022-502737-26-00

EudraCT number

2019-002442-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the surgical specimen after complete gross surgical resection of head and neck carcinoma

Secondary objectives 4

1. to evaluate the specificity of intraoperative near-infrared fluorescence imaging, i.e. its capacity to differentiate healthy margins from head and neck cancers.
2. to evaluate the positive predictive value of intraoperative near-infrared fluorescence imaging on the operating bed, during a new surgical resection after extemporaneous examination of suspicious areas.
3. analyze the mapping and kinetics of the tumor to background ratio (TBR) for head and neck cancers.
4. To determine the importance of near-infrared fluorescence imaging combined with ICG in robotic transoral surgery via the Intuitive Firefly module compared to near-infrared fluorescence imaging combined with ICG in open surgery: sensitivity, specificity, mapping and kinetics of the tumor to background Ratio

Conditions and MedDRA coding

epidermoid carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Male or female, 18 years of age or older - ECOG performance status 0-2 - Histological confirmation of epidermoid carcinoma - Location of the primary tumor in the oral cavity or oropharynx - Operable disease with the intention of complete resection - Negative serum or urine pregnancy test (depending on the center's practice) within 14 days prior to systemic injection of indocyanine green (pre-operative visit), for women of childbearing potential - informed consent form signed by the patient - Patient affiliated with a social security plan or beneficiary of a similar plan. - Patient must understand, sign and date the informed consent form prior to any protocol specific procedure. Patient must be able and willing to comply with study visits and procedures outlined in the protocol.

Exclusion criteria 1

1. Severe medical co-morbidities or contraindications to surgery - Non-operable primary tumor - History of head and neck cancer in the last 5 years - History of radiation treatment for head and neck cancer - Metastatic cancer - Tumors with necrotic areas on preoperative imaging - 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 breastfeeding woman - Allergy or hypersensitivity to the administered product (its active substance or other ingredients), to iodized products or to shellfish. - 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 ICG extinction (i.e. anticonvulsants, haloperidol and Heparin). - Patients under guardianship or deprived of liberty by judicial or administrative decision or patients unable to give consent. - Patients unable to comply with the medical follow-up of the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sensitivity of real-time near-infrared fluorescence imaging in the first and last sections in which pathological examination confirms the presence of microscopic residual disease after complete gross surgical resection.

Secondary endpoints 1

1. Specificity of real-time near-infrared fluorescence imaging to detect healthy margins in real time. - Positive predictive value of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the surgical bed after resection. - Tumor to background ratio (TBR) mapping and kinetics - Number of patients with adverse events and their grade to measure safety and tolerability

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Gustave Roussy

Sponsor organisation

Institut Gustave Roussy

Address

114 Rue Edouard Vaillant

City

Villejuif

Postcode

94800

Country

France

Scientific contact point

Organisation

Institut Gustave Roussy

Contact name

Regulatory Affairs Officer

Public contact point

Organisation

Institut Gustave Roussy

Contact name

Regulatory Affairs Officer

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications