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FLuorescent Assisted Surgery for Head and neck cancer: Perioperative Optical Imaging in Neck dissection and Transoral robotic surgery (FLASHPOINT)
EU CTIS ID: 2025-522845-23-00
What this study is testing
OPSCC cohort: Evaluate the diagnostic performance of FG001 OSCC cohort: Evaluate the diagnostic performance of FG001
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Location of tumor or neck metastases suitable for optical imaging
- Subjects aged 18 years or older
- Capable of understanding and giving written informed consent
- Subject must not previously have received the IMP
- 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
You likely can't join if
- Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck.
- Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP
- Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
- Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator
- 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)
- 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.
See the full eligibility criteria
Who can join
- 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.
- Location of tumor or neck metastases suitable for optical imaging
- Subjects aged 18 years or older
- Capable of understanding and giving written informed consent
- Subject must not previously have received the IMP
- 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
- 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)
What rules you out
- Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck.
- Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP
- Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
- Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator
- 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)
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.