AzTrials
AzTrials

CancerNCT06304155

Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer

An observational study of Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Diagnostic efficacy,SUV
How many people
40 participants
Where
1 siteChina
Study dates
1 Jan 2024to 1 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

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

Study population: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn.

Who may be able to join

  • Patients with high clinical suspicion of oropharyngeal and laryngeal cancer: CT and MR examinations reveal space occupying lesions in the oropharynx and laryngopharynx, with high suspicion of laryngeal cancer;
  • Recently diagnosed patients: patients who have recently been diagnosed with oropharyngeal cancer and laryngeal cancer, have not undergone surgical resection but are willing to undergo surgery;
  • Patients who have been diagnosed with oropharyngeal and laryngeal cancer and have undergone concurrent radiotherapy, chemotherapy, or immunotherapy, and are preparing to undergo preoperative staging in the near future;
  • Patients with high suspicion of oropharyngeal and laryngeal cancer through imaging examination, and later confirmed by pathology as non oropharyngeal or laryngeal cancer;
  • Patient age ≥ 18 years old;
  • The patient voluntarily participates and signs an informed consent form.

Who cannot join

  • Patients who refuse to undergo surgery;
  • Patients highly suspected of lymphoma or metastasis in clinical or imaging studies;
  • Patients with multiple neck metastases identified through imaging examination that cannot be surgically treated;
  • Patients with malignant tumors in other parts of the body found through imaging examination that cannot be operated on;
  • Pregnancy or lactation period;
  • The imaging quality is poor and cannot be used for diagnosis and evaluation;
  • Patients with contraindications for MR examination.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Department of Nuclear Medicine, Daping Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400010

    Xiao Chen, Ph.D, 15922970174, xiaochen229@foxmail.com

    Recruiting

Other trials in China

About this study

According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods.

Read the detailed description

This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to January 1,2026.The detailed description is as follows:

  1. Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
  2. Clinical data collection: Record the course of disease, CT examination, MR examination, laryngoscopy examination, PET/CT examination, PET/MR examination, and other information of all patients.
  3. CT or MRI image analysis: Record the location and number of lesions, measure the long diameter of the primary and metastatic lesions, and the short diameter of lymph nodes on CT or MRI images.
  4. PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptakevalue (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
  5. Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P<0.05 indicates a statistically significant difference.
Conditions
Cancer
Being tested
Diagnostic efficacy,SUV
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic efficacy,SUVDiagnostic test

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.

    Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic efficacy

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.

    Measured: Completed within half year after end of the study

Secondary outcomes (1)

  1. SUV

    Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

    Measured: Completed within half year after end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Jan 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304155
Sponsor's protocol ID
202437
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Steuer CE, El-Deiry M, Parks JR, Higgins KA, Saba NF. An update on larynx cancer. CA Cancer J Clin. 2017 Jan;67(1):31-50. doi: 10.3322/caac.21386. Epub 2016 Nov 29.

    PubMed 27898173

  • Xia R, Wang X, Cheng J, Li X, Sun J, Zeng Q, Hu D, You J, Xiong Y, Chen X. Head-to-head comparison of [18F]FAPI-42 and [18F]FDG PET/CT in the evaluation of laryngeal squamous cell carcinoma. Eur J Nucl Med Mol Imaging. 2025 Jul;52(9):3101-3113. doi: 10.1007/s00259-025-07180-8. Epub 2025 Mar 8.

    PubMed 40055207

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 China. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic efficacy (time frame: Completed within half year after end of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06304155, which also lists 2 linked publications.

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 15 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in