Evaluation of FG001 imaging agent in patients with oropharyngeal and oral squamous cell carcinoma undergoing transoral robotic surgery or neck dissection

2 1 1

What is this study about?

The study examines two head and neck cancers: Oropharyngeal Squamous Cell Carcinoma and Oral Squamous Cell Carcinoma with neck metastases. Participants receive a single dose of an experimental imaging agent called FG001 through an intravenous injection before their scheduled operation. The agent makes cancer cells glow, allowing a special camera that detects fluorescence to help the surgeon see the tumor during the procedure. The purpose of the study is to determine how well the agent identifies cancer tissue while surgery is being performed.

On the day of surgery, the drug is given and then the patient undergoes either a minimally invasive robotic removal of the throat tumor using transoral robotic surgery or a removal of lymph nodes in the neck with neck dissection surgery. During the operation the surgeon watches the glowing signal and notes whether cancer is visible. After removal, the tissue is examined under a microscope to confirm whether the glowing areas matched the cancer. The study follows each participant for a short period after surgery to collect the imaging and pathology results.

1 initial visit and consent

the patient arrives at the study site on the scheduled day and meets with study staff to review the study information.

written informed consent is obtained after the patient confirms understanding of the study purpose and procedures.

2 baseline assessments

the patient undergoes a physical examination and routine laboratory tests to confirm eligibility.

baseline imaging of the head and neck area is performed to document the location of the tumor and any lymph node involvement.

3 administration of study drug

a single intravenous injection of fg001 is given.

the dose is 0.45 mg/kg (milligrams per kilogram of body weight) and the drug is supplied in a vial for intravenous use.

the injection is performed by a qualified clinician in a controlled setting.

4 pre‑operative waiting period

after the injection, the patient rests for a short period to allow the drug to circulate and accumulate in tumor tissue.

no additional medication is given during this time.

5 surgical procedure

if the patient has oropharyngeal squamous cell carcinoma, a transoral robotic surgery (tors) is performed to remove the primary tumor.

if the patient has oral squamous cell carcinoma with neck metastases, a neck dissection surgery is performed to remove lymph nodes in the neck.

the chosen surgery is performed under general anesthesia in the operating room.

6 intra‑operative fluorescence imaging

during the surgery, a special imaging system detects the fluorescence emitted by fg001 to help the surgeon identify tumor tissue and metastatic lymph nodes.

the surgeon records the tumor‑to‑background ratio and notes any residual fluorescence in the resection cavity.

7 tissue collection and pathology

resected tumor and lymph node specimens are sent to the pathology laboratory.

histopathology results are used as the reference standard to evaluate the accuracy of the fluorescence imaging.

8 post‑operative follow‑up

the patient returns for scheduled follow‑up visits to assess wound healing, monitor for any adverse effects, and review the imaging and pathology findings.

additional safety assessments may be performed during these visits.

9 completion of trial participation

after the final follow‑up visit and completion of all study assessments, the patient’s participation in the trial is concluded.

the patient receives a summary of the study results that are relevant to their care.

Who Can Join the Study?

Must be a new (untreated) patient with a biopsy‑confirmed diagnosis of either oropharyngeal squamous cell carcinoma (OPSCC) (early stage T1‑T2, with or without spread to nearby lymph nodes) who is scheduled for curative transoral robotic surgery (TORS), or oral squamous cell carcinoma (OSCC) with biopsy‑confirmed spread to lymph nodes (any size T1‑T4, N+) who is scheduled for curative neck‑dissection surgery.
The tumor or any neck metastasis must be located in an area that can be examined with the study’s optical imaging device.
Must be 18 years of age or older.
Must be able to understand the study information and sign a written informed consent form.
Must not have received the study drug (the investigational medicinal product, or IMP) before.
If male, must agree to use a barrier method of contraception (such as a condom) during the trial and for 30 days after the last dose, and must not donate sperm during that time.
If female and able to become pregnant, must agree to use an adequate method of contraception during the trial and for 30 days after the last dose. Acceptable methods include an intrauterine device, hormonal pills, injections, implants, patches, or vaginal rings. Women who are surgically sterilized, have had a hysterectomy or removal of both ovaries, or are post‑menopausal are also considered protected.

Who Cannot Join the Study?

Previous chemotherapy, major surgery, or radiotherapy to the mouth, throat, or neck – you cannot have had cancer‑killing medicines, a large operation, or strong radiation treatment in those areas before joining the study.
Allergy or hypersensitivity to indocyanine green (ICG) or any part of the study drug – you must not be allergic to ICG, which is a special dye used in the test, or to any ingredient of the investigational medicine.
Pregnant or breast‑feeding women – women who are pregnant (a positive pregnancy test) or are feeding a baby cannot take part.
Overall health not good enough for the study – if the doctor thinks your general condition or other existing illnesses make it unsafe for you to join, you will be excluded.
Existing liver or kidney problems – this includes:
- Liver enzymes called AST or ALT that are more than three times higher than normal, or a bilirubin level (a substance made by the liver) more than 1.5 times normal, unless it is due to a harmless condition called Gilbert’s syndrome.
- Kidney function measured as an estimated GFR (glomerular filtration rate) lower than 45 ml/min/1.73 m², which indicates reduced kidney ability.
Abnormal blood clotting tests – you cannot have any of the following:
- Platelet count (cells that help stop bleeding) below 100,000 per microliter.
- aPTT (a test that measures how long blood takes to clot) more than 1.5 times the normal limit.
- INR (another clotting measurement) higher than 1.71, unless you are on blood‑thinning medication and the doctor decides it is safe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

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 an IV injection. In the study it is used to help doctors see the cancer more clearly on special scans, so they can check how well it works at finding tumors in the throat and mouth.

Transoral robotic surgery is a minimally invasive procedure where a surgeon uses a small robot to remove cancer from the throat through the mouth, without needing large cuts. This technique helps to treat oropharyngeal cancer while aiming for quicker recovery.

Neck dissection surgery is a procedure to remove lymph nodes and surrounding tissue in the neck that may contain cancer spread from oral tumors. It helps doctors assess and treat regional lymph node metastases.

Oral squamous cell carcinoma with neck metastases – A cancer that starts in the lining of the mouth and can spread to lymph nodes in the neck. It begins as a small lesion that grows and invades nearby tissues. Cancer cells travel through lymphatic vessels to form additional tumors in the neck nodes. The disease may cause swelling, pain, or changes in speech and swallowing as it advances.
Oropharyngeal squamous cell carcinoma – A cancer that originates in the lining of the throat behind the mouth, including the tonsils and base of the tongue. It starts as a small patch that enlarges and infiltrates surrounding tissues. As it grows, it can spread to nearby lymph nodes and deeper structures. The condition may lead to sore throat, difficulty swallowing, or changes in voice as it progresses.

Trial ID:

2025-522845-23-00

Protocol code:

RH-FG001-02

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Evaluation of FG001 imaging agent in patients with oropharyngeal and oral squamous cell carcinoma undergoing transoral robotic surgery or neck dissection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?