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RecruitingNCT06304155Updated Mar 15, 2024

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

An observational study in Cancer, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Cancer

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03

In context

Laryngeal Neoplasms

244 studies on the registry are indexed under Laryngeal Neoplasms; 63 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 54 observational studies indexed under Laryngeal Neoplasms.

Browse Laryngeal Neoplasms studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  1. 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;
  2. 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;
  3. 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;
  4. Patients with high suspicion of oropharyngeal and laryngeal cancer through imaging examination, and later confirmed by pathology as non oropharyngeal or laryngeal cancer;
  5. Patient age ≥ 18 years old;
  6. The patient voluntarily participates and signs an informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients who refuse to undergo surgery;
  2. Patients highly suspected of lymphoma or metastasis in clinical or imaging studies;
  3. Patients with multiple neck metastases identified through imaging examination that cannot be surgically treated;
  4. Patients with malignant tumors in other parts of the body found through imaging examination that cannot be operated on;
  5. Pregnancy or lactation period;
  6. The imaging quality is poor and cannot be used for diagnosis and evaluation;
  7. Patients with contraindications for MR examination.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDiagnostic efficacy,SUV

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Completed within half year after end of the study

Secondary outcomes

  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.

    Time frame: Completed within half year after end of the study

07

Study locations

1 of 1 sites recruiting
  • Department of Nuclear Medicine, Daping Hospital of Army Medical University
    Chongqing, Chongqing 400010, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06304155
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible party
Xiao Chen (Director of Nuclear Medicine Department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Principal investigator
First posted
Mar 12, 2024
Start date
Jan 1, 2024
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Mar 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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