Fluorescent Imaging Agent FG001 During Surgery for Mouth and Throat Cancer
Tests an imaging agent used during surgery in adults with mouth or throat cancer.
Plain-language title generated from the registry record
Registry title: FLuorescent Assisted Surgery for Head and neck cancer: Perioperative Optical Imaging in Neck dissection and Transoral robotic surgery (FLASHPOINT)
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mouth or throat (oropharynx) cancer who have not yet been treated and are scheduled for surgery. The trial tests an imaging agent, FG001, during surgery.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Biopsy-proven oropharyngeal squamous cell carcinoma (T1–T2, with or without neck lymph node spread) planned for transoral robotic surgery, or oral squamous cell carcinoma with neck lymph node spread (T1-T4, N+) planned for neck dissection surgery. The tumour or neck spread must be in a place where optical imaging can be used.
- Earlier treatment
- Must be untreated: no earlier chemotherapy, major surgery or radiotherapy to the mouth, throat or neck. Must not have received the trial imaging agent before.
Main reasons for not taking part
- Known allergy to indocyanine green (ICG) or any other part of the imaging agent
- Pregnant or breast-feeding
- Liver or kidney problems at the levels set in the record (AST/ALT, bilirubin or eGFR)
- Abnormal blood clotting results (platelets, aPTT or INR)
- General health or other illnesses that the investigator judges unfit for the trial
Read by machine on 9 November 2026.
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Rigshospitalet
- Trial code
- EU 2025-522845-23-00
- Record updated
- 21 October 2026
- Original description
OPSCC cohort: Evaluate the diagnostic performance of FG001Read full original descriptionShow less
An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) in combination with transoral robotic surgery for oropharyngeal squamous cell carcinoma and neck dissection surgery for oral squamous cell carcinoma with regional lymph node metastases
OPSCC cohort: Evaluate the diagnostic performance of FG001
OSCC cohort: Evaluate the diagnostic performance of FG001
Inclusion: 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).
Exclusion: Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck; Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion); Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP; 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; Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator.