FLuorescent Assisted Surgery for Head and neck cancer: Perioperative Optical Imaging in Neck dissection and Transoral robotic surgery (FLASHPOINT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-06-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

FluoGuide A/S: in kind supply of IMP. · Candys Foundation: non trial specific grant.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy

OPSCC cohort:
Evaluate the diagnostic performance of FG001

OSCC cohort:
Evaluate the diagnostic performance of FG001

Secondary objectives 4

1. OPSCC cohort: Evaluate the imaging performance of FG001
2. OPSCC cohort: Assess whether residual fluorescence after completion of planned resection correlates with residual disease
3. OSCC cohort: Characterize node-level diagnostic performance of FG001 for metastatic lymph node detection
4. OSCC cohort: Evaluate the imaging performance of FG001

Conditions and MedDRA coding

Oral Squamous Cell Carcinoma with neck metastases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Naive subjects with either: Biopsy verified primary OPSCC, with or without regional metastases (T1–T2, N+/N−), scheduled for curative intended TORS OR OSCC and biopsy verified regional lymph node metastases (T1-T4, N+) scheduled for curative intended neck dissection surgery.
2. Location of tumor or neck metastases suitable for optical imaging
3. Subjects aged 18 years or older
4. Capable of understanding and giving written informed consent
5. Subject must not previously have received the IMP
6. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after EoT and avoid sperm donation during this period
7. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after EoT. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)

Exclusion criteria 6

1. Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck.
2. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP
3. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
4. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator
5. Pre-existing hepatic (Aspartate transaminase (AST) and/or alanine transaminase (ALT) >3 times the upper limit of normal; or Total bilirubin >1.5 times the upper limit of normal unless the elevation is attributable to Gilbert’s syndrome) and/or renal insufficiency (Estimated GFR (eGFR) < 45 ml/min/1.73m2)
6. Abnormal coagulation profile with any of the following: Platelets < 100 ×10^9/L (equivalent to <100,000/µL) and/or aPTT >1.5x upper limit of normal and/or INR >1.71. NOTE: If a subject is being treated with anticoagulants and the INR is borderline (approximately 1.8) and the PI judges the subject to be eligible with no safety concerns, such subject may be deemed eligible for the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. OPSCC cohort: Sensitivity of FG001 for detection of primary OPSCC during TORS, using histopathology of the resected primary tumor specimen as reference standard.
2. OSCC cohort: Node-level sensitivity of FG001 for detection of metastatic lymph nodes, using lymph node histopathology as reference standard.

Secondary endpoints 4

1. OPSCC cohort: Tumor-to-background ratio (TBR_mean and TBR_max) calculated from selected fluorescence images comparing tumor Region of interest (ROI) and adjacent non-tumor tissue.
2. OPSCC cohort: Residual fluorescence in the resection cavity after completion of planned resection (present/absent) will be recorded together with residual disease status based on histopathology of fluorescence-targeted fresh-frozen-section biopsies.
3. OSCC cohort: Node-level specificity, PPV, and NPV for metastatic lymph node detection; Receiver operating characteristic (ROC) analysis (as applicable), using lymph node histopathology as reference standard.
4. OSCC cohort: Signal-to-background ratio (SBR) and fluorescence intensity of dissected lymph nodes calculated from selected fluorescence images using signal ROI and adjacent tissue

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Andreas Kjær

Public contact point

Organisation

Rigshospitalet

Contact name

Hannes Sjölander

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 8 files

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

Application history

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