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

March 13, 2024 updated by: Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • Department of Nuclear Medicine, Daping Hospital of Army Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy
Time Frame: Completed within half year after end of the study
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.
Completed within half year after end of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV
Time Frame: Completed within half year after end of the study
Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
Completed within half year after end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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