Head and Neck Squamous Cell Carcinoma HNSCCPhase 2FAPIHNNCT06794372
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas
A Phase 2 study testing [68Ga]Ga-FAPI-46 PET/CT in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by John O. Prior at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- [68Ga]Ga-FAPI-46 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Assistant contact
Switzerland1 site, 1 recruiting
- Recruiting
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, 1011
John O Prior, MD, PhD, +41 21 314 4348, john.prior@chuv.ch
Niklaus Schaefer, MD
About this study
Official title: [68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas
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. CAFs exert their influence through intricate mechanisms, including the remodeling of the extracellular matrix by secreting proteins such as collagen and fibronectin. This process enhances the structural support for cancer cell invasion into adjacent tissues. Additionally, CAFs play a central role in promoting angiogenesis, ensuring an adequate blood supply to the tumor, which may also facilitate the entry of cancer cells into the bloodstream. Through modulation of immune responses within the tumor microenvironment, CAFs establish an immunosuppressive milieu, providing a permissive environment for cancer cell survival and dissemination. Collectively, the orchestrated activities of CAFs contribute to the preparation of a metastatic niche, influencing the microenvironment at both primary and secondary sites and enhancing the likelihood of successful metastasis.
Employing [68Ga]Ga-FAPI-46 PET/CT imaging to target activated CAFs may hold the potential to discern lymph nodes (LNs) predisposed to future metastases in HNSCC. The use of this imaging modality offers a unique opportunity to visualize and assess the presence and activity of CAFs within the tumor microenvironment. By targeting the fibroblast activation protein (FAP), a receptor enriched on CAFs, this imaging approach provides a specific and sensitive mean to identify regions where the microenvironment may favor metastatic progression.
In this research endeavor, the primary objective is to highlight the additional value of [68Ga]Ga-FAPI-46 PET/CT into the standard pre-surgical imaging protocol. Additionally, the study will evaluate the efficacy of FAP positon emission tomography (PET) in primary tumor delineation. Imaging based on [68Ga]Ga-FAPI-46 allows the identification of CAFs, specifically by exploiting their increased FAP expression. The study aims also to systematically compare the [68Ga]Ga-FAPI-46 PET/CT signals with the characteristics of resected lymph nodes, seeking to ascertain the capability of FAPI PET imaging in identifying premetastatic conditions. By comparing the [68Ga]Ga-FAPI-46 PET signal and the histopathological features of resected lymph nodes, the goal is to validate the potential of [68Ga]Ga-FAPI-46 PET imaging as a tool for early detection of premalignant or metastatic conditions in the lymphatic system before surgical intervention. The ability to pinpoint lymph nodes at risk for future metastases could revolutionize clinical decision-making, by facilitating a more nuanced understanding of disease spread, thereby informing personalized treatment strategies and potentially improving patient outcomes.
Read the detailed description
[68Ga]Ga-FAPI-46 PET/CT is an advanced imaging technique utilized in nuclear medicine for the evaluation of various cancers. The imaging agent [68Ga]Ga-FAPI-46 specifically targets FAP, a protein overexpressed by CAFs in the tumor microenvironment. This targeted approach allows for precise visualization of FAP-positive tumors, aiding in the detection, staging, and assessment of therapeutic response. The integration of PET and CT modalities provides both functional and anatomical information, enhancing the accuracy of the imaging results. In this study, the investigators will specifically evaluate the application of [68Ga]Ga-FAPI-46 PET/CT in patients diagnosed with HNSCC who are scheduled for primary clinical resection. This research aims to explore the potential of [68Ga]Ga-FAPI-46 PET/CT in guiding treatment decisions and optimizing the management of HNSCC, contributing valuable insights to the growing knowledge in precision oncology.
Patients with confirmed HNSCC and planned to undergo tumor and LN dissection surgery will be recruited for this project. The included patients will follow their standard-of-care clinical investigations according to current guideline-based recommendations.
Patients will receive [68Ga]Ga-FAPI-46 in a dose of 2MBq/kg (+/-15%) as an IV injection. The total administered dose will be between 80 and 200MBq. 60 minutes (+/- 10min) after the injection, low-dose, non-contrast-enhanced PET/CT will be acquired for about 20 minutes.
- Being tested
- [68Ga]Ga-FAPI-46 PET/CT
- Keywords
- Head and Neck Squamous Cell Carcinoma, Cancer-associated fibroblasts, PET/CT, Lymph nodes, Tumor microenvironment, Fibroblast activation protein
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46 PET/CTDrug
[68Ga]Ga-FAPI-46 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| HNSCC patients | Experimental | Patients with operable head and neck cancer presenting histologically proven HNSCC, planned to undergo surgery (tumour and lymph node dissection), and who will benefit, as standard of care, from cervical MRI, ceCT and 18F-FDG PET/CT. Receives: Drug: [68Ga]Ga-FAPI-46 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size
The tumor size (mm*mm) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor volume
The tumor volume (mm^3) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor SUVmax
The SUVmax of the tumor measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: number of lesions
The number of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion site
The site of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion size
The size (mm*mm) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion volume
The volume (mm^3) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion SUVmax
The SUVmax of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: TNM tumor stage
The TNM stage calculated by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
Secondary outcomes (1)
Ability of [68Ga]Ga-FAPI-46 PET/CT to visualize tumor infiltration in lymph nodes
Histopathology of clinically indicated resected lymph node specimen will be performed. [68Ga]Ga-FAPI-46 PET/CT results and tumor infiltration findings by histology will be compared (lesions defined positive/negative as a result of the two techniques).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John O. Prior
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- Niklaus Schaefer, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794372
- Sponsor's protocol ID
- FAPIHN
- Other IDs
- 2024-01881
- Acronym
- FAPIHN
- Status last verified
- May 2026
- First submitted
- 24 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT06794372
- Acronym / sponsor ID
- FAPIHN / FAPIHN
- Keywords
- Head and Neck Squamous Cell Carcinoma, Cancer-associated fibroblasts, PET/CT, Lymph nodes, Tumor microenvironment, Fibroblast activation protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John O. PriorUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. CAFs exert their influence through intricate mechanisms, including the remodeling of the extracellular matrix by secreting proteins such as collagen and fibronectin. This process enhances the structural support for cancer cell invasion into adjacent tissues. Additionally, CAFs play a central role in promoting angiogenesis, ensuring an adequate blood supply to the tumor, which may also facilitate the entry of cancer cells into the bloodstream. Through modulation of immune responses within the tumor microenvironment, CAFs establish an immunosuppressive milieu, providing a permissive environment for cancer cell survival and dissemination. Collectively, the orchestrated activities of CAFs contribute to the preparation of a metastatic niche, influencing the microenvironment at both primary and secondary sites and enhancing the likelihood of successful metastasis.
Employing [68Ga]Ga-FAPI-46 PET/CT imaging to target activated CAFs may hold the potential to discern lymph nodes (LNs) predisposed to future metastases in HNSCC. The use of this imaging modality offers a unique opportunity to visualize and assess the presence and activity of CAFs within the tumor microenvironment. By targeting the fibroblast activation protein (FAP), a receptor enriched on CAFs, this imaging approach provides a specific and sensitive mean to identify regions where the microenvironment may favor metastatic progression.
In this research endeavor, the primary objective is to highlight the additional value of [68Ga]Ga-FAPI-46 PET/CT into the standard pre-surgical imaging protocol. Additionally, the study will evaluate the efficacy of FAP positon emission tomography (PET) in primary tumor delineation. Imaging based on [68Ga]Ga-FAPI-46 allows the identification of CAFs, specifically by exploiting their increased FAP expression. The study aims also to systematically compare the [68Ga]Ga-FAPI-46 PET/CT signals with the characteristics of resected lymph nodes, seeking to ascertain the capability of FAPI PET imaging in identifying premetastatic conditions. By comparing the [68Ga]Ga-FAPI-46 PET signal and the histopathological features of resected lymph nodes, the goal is to validate the potential of [68Ga]Ga-FAPI-46 PET imaging as a tool for early detection of premalignant or metastatic conditions in the lymphatic system before surgical intervention. The ability to pinpoint lymph nodes at risk for future metastases could revolutionize clinical decision-making, by facilitating a more nuanced understanding of disease spread, thereby informing personalized treatment strategies and potentially improving patient outcomes.
Detailed description
[68Ga]Ga-FAPI-46 PET/CT is an advanced imaging technique utilized in nuclear medicine for the evaluation of various cancers. The imaging agent [68Ga]Ga-FAPI-46 specifically targets FAP, a protein overexpressed by CAFs in the tumor microenvironment. This targeted approach allows for precise visualization of FAP-positive tumors, aiding in the detection, staging, and assessment of therapeutic response. The integration of PET and CT modalities provides both functional and anatomical information, enhancing the accuracy of the imaging results. In this study, the investigators will specifically evaluate the application of [68Ga]Ga-FAPI-46 PET/CT in patients diagnosed with HNSCC who are scheduled for primary clinical resection. This research aims to explore the potential of [68Ga]Ga-FAPI-46 PET/CT in guiding treatment decisions and optimizing the management of HNSCC, contributing valuable insights to the growing knowledge in precision oncology.
Patients with confirmed HNSCC and planned to undergo tumor and LN dissection surgery will be recruited for this project. The included patients will follow their standard-of-care clinical investigations according to current guideline-based recommendations.
Patients will receive [68Ga]Ga-FAPI-46 in a dose of 2MBq/kg (+/-15%) as an IV injection. The total administered dose will be between 80 and 200MBq. 60 minutes (+/- 10min) after the injection, low-dose, non-contrast-enhanced PET/CT will be acquired for about 20 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HNSCC patients | Experimental | Drug: [68Ga]Ga-FAPI-46 PET/CTPatients with operable head and neck cancer presenting histologically proven HNSCC, planned to undergo surgery (tumour and lymph node dissection), and who will benefit, as standard of care, from cervical MRI, ceCT and 18F-FDG PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI-46 PET/CT[68Ga]Ga-FAPI-46 PET/CT | Drug | HNSCC patients |
Primary outcome
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size
Time frame: 6 weeks
The tumor size (mm*mm) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor volume
Time frame: 6 weeks
The tumor volume (mm^3) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor SUVmax
Time frame: 6 weeks
The SUVmax of the tumor measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
[68Ga]Ga-FAPI-46 PET/CT imaging results: number of lesions
Time frame: 6 weeks
The number of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion site
Time frame: 6 weeks
The site of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion size
Time frame: 6 weeks
The size (mm*mm) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion volume
Time frame: 6 weeks
The volume (mm^3) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion SUVmax
Time frame: 6 weeks
The SUVmax of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
[68Ga]Ga-FAPI-46 PET/CT imaging results: TNM tumor stage
Time frame: 6 weeks
The TNM stage calculated by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
1 secondary outcome
Ability of [68Ga]Ga-FAPI-46 PET/CT to visualize tumor infiltration in lymph nodes
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Squamous Cell Carcinoma HNSCC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assistant contact
Niklaus Schaefer, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-FAPI-46 PET/CT in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by John O. Prior at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John O Prior, MD, PhD (+41 21 314 4348, john.prior@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size (time frame: 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.