BridgeMD
New treatment option for Head and Neck Squamous Cell Carcinoma HNSCC
Official title [68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas
ClinicalTrials.gov ID: NCT06794372
What this study is testing
What is [68Ga]Ga-FAPI-46 PET/CT?
[68Ga]Ga-FAPI-46 PET/CT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma hnscc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The trial focuses on assessing the role of [68Ga]Ga-FAPI-46 in head and neck squamous cell carcinomas (HNSCC) staging before surgery. In the context of metastasis, cancer-associated fibroblasts (CAFs) emerge as pivotal contributors to the creation of a microenvironment conducive to future metastases.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old
- Karnofsky index ≥80%
- Patients with operable head and neck cancer presenting histologically proven HNSCC (including Oral Cavity Cancer, Pharyngeal Cancer, Laryngeal Cancer)
- Patients with at least one nodal metastasis
- Patients scheduled for neck dissection
You likely can't join if
- Known pregnancy or ongoing breast feeding
- Claustrophobia
- Severe renal insufficiency (GFR\<30 mL/min/1,73 m2)
- Liver enzymes (ALAT, ASAT)\>5 times the standard upper limit
- Bilirubin\>3 times the standard upper limit
- Hemoglobin\<8 g/dL
See the full eligibility criteria
- Age ≥18 years old
- Karnofsky index ≥80%
- Patients with operable head and neck cancer presenting histologically proven HNSCC (including Oral Cavity Cancer, Pharyngeal Cancer, Laryngeal Cancer)
- Patients with at least one nodal metastasis
- Patients scheduled for neck dissection
- SOC imaging (MRI, ceCT and 18F-FDG-PET/CT) performed as pre-surgery exams
- Written informed consent obtained
- Known pregnancy or ongoing breast feeding
- Claustrophobia
- Severe renal insufficiency (GFR\<30 mL/min/1,73 m2)
- Liver enzymes (ALAT, ASAT)\>5 times the standard upper limit
- Bilirubin\>3 times the standard upper limit
- Hemoglobin\<8 g/dL
- Absolute neutrophil count\<1000/mm3
- Platelets\<75000/µL
- insufficient knowledge of project language, inability to give consent or to follow trial-associated procedures
- the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.