Evaluation of FG001 Imaging Agent in Patients with Oropharyngeal Squamous Cell Carcinoma or Oral Squamous Cell Carcinoma with Neck Metastases Undergoing Surgery

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What is this study about?

The study focuses on two types of head‑and‑neck cancer: oropharyngeal squamous cell carcinoma, which occurs in the back of the throat, and oral squamous cell carcinoma that has spread to the neck lymph nodes. Participants will receive a single dose of an investigational imaging agent called FG001 through an intravenous injection. The agent is designed to glow under special light, helping surgeons see the tumor and any affected lymph nodes during procedures such as transoral robotic surgery for throat tumors and neck dissection for mouth cancers.

The purpose of the study is to evaluate how well the glowing agent can identify cancer tissue during surgery. After the dose is given, the patient undergoes the planned operation, during which the surgeon uses a special camera to look for the fluorescent signal. Tissue that appears bright is removed and later examined under a microscope to confirm whether cancer is present.

Researchers will compare the imaging results with the laboratory findings to see how accurately the agent detects the primary tumor and any spread to lymph nodes. Information such as the brightness of the signal compared to surrounding tissue and whether any glowing areas remain after the tumor is removed will be recorded to assess the usefulness of this new imaging approach.

1 initial visit and consent

you attend the first visit after being accepted into the study and sign the consent form.

the study team records your medical history, current medications, and performs any required laboratory tests.

2 baseline assessments

imaging studies and physical examinations are completed to document the extent of your cancer before any study procedures.

3 pre‑surgical preparation

you are given instructions about fasting and other preparations required for the upcoming surgery.

the date of your surgery is scheduled.

4 administration of <b>fg001</b>

on the day of surgery, a single intravenous injection of fg001 is given.

the dose is 0.45 mg per kilogram of your body weight, delivered from a vial prepared for iv use.

the injection is administered shortly before the surgical procedure begins.

5 surgical procedure with fluorescence imaging

for oropharyngeal cancer, transoral robotic surgery (tors) is performed; for oral cancer with neck metastases, a neck dissection surgery is performed.

during the operation, a special camera detects the fluorescence from fg001 to help locate the tumor and any metastatic lymph nodes.

6 tissue collection and analysis

the tumor that is removed is sent to the pathology laboratory for standard histopathology.

additional small samples may be taken from areas that show fluorescence to confirm whether cancer cells are present.

7 postoperative monitoring

after surgery you are observed in the recovery area for any immediate reactions to the study drug and for normal postoperative recovery.

8 follow‑up assessments

once pathology results are available, the study team evaluates the performance of fg001 in detecting tumor tissue.

no further doses of the study drug are given; routine postoperative follow‑up continues as usual.

Who Can Join the Study?

Have a newly diagnosed (biopsy‑verified means a tissue sample has confirmed the cancer) primary oropharyngeal (throat) or oral (mouth) squamous cell carcinoma, with or without spread to nearby lymph nodes (small glands that can carry cancer), and be scheduled for surgery that aims to cure the disease (either transoral robotic surgery (TORS) for throat cancer or neck‑dissection surgery for mouth cancer).
The tumor or the affected lymph nodes must be in a location that can be examined with the study’s optical imaging device.
Be 18 years of age or older.
Be able to understand the study information and sign a written informed consent form.
Must not have received the investigational drug (the study medication) before joining the trial.
Male participants must agree to use barrier contraception (for example, a condom) during the trial and for 30 days after the end of treatment, and must not donate sperm during that time.
Female participants who could become pregnant must agree to use an effective method of contraception during the trial and for 30 days after the end of treatment. Acceptable methods include an intrauterine device, hormonal pills, injections, implant, patch, or vaginal ring. Women who have had surgical sterilization (such as tubal ligation, hysterectomy, or removal of both ovaries) or who are post‑menopausal are also eligible.

Who Cannot Join the Study?

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 ingredient of the study drug.
Being pregnant or breast‑feeding (a positive pregnancy test before joining the study).
Overall health or other medical problems that the doctor decides make participation unsafe.
Pre‑existing liver problems (levels of AST or ALT more than three times the normal range, or total bilirubin more than 1.5 times normal unless caused by Gilbert’s syndrome) or kidney problems (an estimated glomerular filtration rate (eGFR) lower than 45 ml/min/1.73 m²). AST and ALT are enzymes that show liver injury; bilirubin is a substance that can build up when the liver does not work well; eGFR measures how well the kidneys filter blood.
Abnormal blood‑clotting tests, such as platelet count below 100,000 per microliter, a prolonged aPTT (more than 1.5 times the normal limit), or an INR greater than 1.71. Platelets help stop bleeding, aPTT measures how long it takes blood to clot, and INR is a standardized way to check clotting; people taking blood‑thinners may be allowed if the doctor judges it safe.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.07.2026

Trial locations

Investigated drugs:

FG001

FG001 is an imaging agent that is given through a vein. It helps doctors see the cancer cells more clearly during scans. In this trial, the drug is used to check how well it can detect tumors in patients with throat or mouth cancer.

Transoral robotic surgery is a minimally invasive operation where surgeons use a robot to remove tumors from the throat. The robot provides precise movements, allowing doctors to take out the cancer while causing less damage to surrounding tissue. This procedure is part of the study for patients with oropharyngeal (throat) cancer.

Neck dissection surgery is an operation that removes lymph nodes and nearby tissue in the neck when oral cancer has spread to these areas. The surgery helps doctors treat the cancer and also provides tissue that can be examined to see how well the imaging agent works.

Oral squamous cell carcinoma with cervical lymph node metastasis – It is a cancer that begins in the flat cells lining the mouth and can spread to lymph nodes in the neck. The tumor usually starts as a small ulcer or thickened area that may become larger and more irregular. As it grows, it can invade deeper tissues of the oral cavity and surrounding muscles. Cancer cells may travel through lymphatic vessels and establish new growths in nearby neck lymph nodes. The involvement of these nodes often indicates a more advanced stage of the disease.

Oropharyngeal squamous cell carcinoma – This cancer originates from the flat cells covering the oropharynx, which includes the tonsils, base of tongue, and soft palate. It typically begins as a small, painless lesion that can enlarge over time. The tumor may spread locally to adjacent structures such as the tongue, palate, or pharyngeal walls. Cancer cells can also move into the lymphatic system, reaching regional lymph nodes. Continued growth can lead to further spread within the head and neck region.

Trial ID:

2025-522845-23-00

Protocol code:

RH-FG001-02

Trial Phase:

Therapeutic exploratory (Phase II)

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Evaluation of FG001 Imaging Agent in Patients with Oropharyngeal Squamous Cell Carcinoma or Oral Squamous Cell Carcinoma with Neck Metastases Undergoing Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?