Nuclear MedicineNCT06947759
Application of 18F-FDG PET/MRI for Initial Staging in Locally Advanced Nasopharyngeal Carcinoma
An observational study of Nuclear Medicine and Oncology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This single-center prospective observational study aims to evaluate the feasibility, cost-effectiveness, and clinical value of positron emission tomography/magnetic resonance imaging (PET/MRI) for initial staging in patients with locally advanced nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nuclear Medicine, Oncology
- What is being tested?
- PET/MRI
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2025to 30 Apr 2026
- Phase
- Observational
- 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
Study population: The participants in this study are pathologically diagnosed nasopharyngeal carcinoma (NPC) patients, primarily focusing on those with locally advanced staging (cT3-4/N2-N3), who have not yet received any treatment related to NPC. Participants must be 18 years or older, in good physical condition, and able to cooperate in completing imaging examinations and treatments.
Who may be able to join
- Pathologically diagnosed with nasopharyngeal carcinoma (NPC) through endoscopic biopsy at the hospital's otolaryngology department.
- Clinically staged as cT3-4/N2-N3.
- Age: 18 years and older.
- Participants must voluntarily sign an informed consent form, acknowledging understanding of the study objectives and potential risks.
Who cannot join
- Patients with poorly controlled diabetes. -Patients with a history of head and neck malignancies or a history of non- head and neck cancers with no evidence of disease for at least 3 years.
- Patients with clinical staging of cT1-2N0-1.
- Patients with factors that may affect PET/MRI image quality, such as implanted metal devices or MRI contraindications, or those with a history of contrast agent allergies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taichung Veterans General Hospital
Taichung
Yi-Chun Liu, MD, 886-23592525 ext. 5601, b9202080@vghtc.gov.tw
About this study
Official title: Application of 18F-FDG PET/MRI as an Initial Staging Procedure for Locally Advanced Nasopharyngeal Carcinoma
This single-center prospective observational study aims to evaluate the feasibility, cost-effectiveness, and clinical value of positron emission tomography/magnetic resonance imaging (PET/MRI) for initial staging in patients with locally advanced nasopharyngeal carcinoma (NPC). It will compare the diagnostic performance of PET/MRI, including sensitivity, specificity, and staging accuracy, with traditional staging methods such as positron emission tomography/computed tomography (PET/CT).
Nasopharyngeal carcinoma is prevalent in Southeast Asia and North Africa, with approximately 5% of newly diagnosed cases presenting with distant metastases. For patients with N2-3 disease and elevated Epstein-Barr virus (EBV) DNA levels, the risk of distant metastasis can reach 27.5%. Accurate detection of distant metastases at diagnosis is crucial for staging and treatment planning. Current National Comprehensive Cancer Network (NCCN) guidelines recommend fluorodeoxyglucose (18F-FDG) PET/CT for staging in locally advanced nasopharyngeal carcinoma, as traditional tools (e.g., chest CT, abdominal ultrasound, bone scans) may yield false-negative results.
PET/MRI, as a novel imaging technique, offers potential advantages such as improved diagnostic accuracy, shorter scan times, and reduced false-positive rates. However, its clinical application is limited by high costs and equipment availability. This study will explore the clinical value and economic feasibility of PET/MRI in nasopharyngeal carcinoma staging, aiming to establish its potential role in improving diagnostic pathways.
Read the detailed description
- Background: Nasopharyngeal carcinoma (NPC) is prevalent in Southeast Asia and North Africa, with 5% of newly diagnosed cases showing distant metastases. For N2-3 stage patients with high Epstein-Barr virus (EBV) DNA levels, the metastasis rate can reach 27.5%. Accurate detection at diagnosis is crucial for staging and treatment planning. While the National Comprehensive Cancer Network (NCCN) recommends fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for staging locally advanced NPC, traditional methods like chest CT or ultrasound may yield false negatives. PET/MRI offers improved accuracy and reduced false positives but is limited by high costs and low accessibility. This study examines the cost-effectiveness and clinical value of PET/MRI in NPC staging.
- Material and methods: This study is a single-center prospective observational study. It will recruit patients aged 18 years or older with pathologically confirmed nasopharyngeal carcinoma (NPC) who have not received any NPC-related treatment and agree to participate. All participants will undergo PET/CT and PET/MRI to compare their diagnostic performance in detecting distant metastases, including sensitivity, specificity, and staging accuracy. The study will also evaluate the time efficiency and cost-effectiveness of PET/MRI to explore its clinical value and limitations.
- Expecting Results:
This study aims to demonstrate that PET/MRI has superior diagnostic accuracy over PET/CT in staging locally advanced nasopharyngeal carcinoma, especially in detecting distant metastases. Despite higher costs, PET/MRI's accuracy may streamline diagnosis, reduce unnecessary tests, and support precise treatment strategies, improving patient outcomes and quality of life. The results will provide evidence for its clinical use and guide future diagnostic improvements.
- Conditions
- Nuclear Medicine, Oncology
- Being tested
- PET/MRI
- Keywords
- PET/MRI, Nasopharyngeal carcinoma, EBV DNA
- Medical subject headings
- Neoplasms, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIRadiation
This single-center prospective observational study targets patients pathologically diagnosed with nasopharyngeal carcinoma (NPC) and clinically staged as cT3-4/N2-N3. Participants will first undergo standard whole-body 18F-FDG PET/CT, followed by localized 18F-FDG PET/MRI of the head and neck within 4 hours. Both imaging procedures will be performed according to standard clinical protocols to ensure data consistency and comparability.
PET/MRI data will be independently interpreted by an experienced nuclear medicine physician and a radiologist. The sensitivity, specificity, and staging accuracy for detecting distant metastases will be analyzed. In cases of disagreement, a third physician will mediate to reach a consensus.
The study team will also record the operational time, direct costs, and potential issues encountered during the examination process for both imaging modalities. All participants will be followed for at least one year to validate imaging results and assess correlation
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of PET/MRI vs. PET/CT in Detecting Distant Metastases in NPC
This study evaluates the sensitivity of PET/MRI compared to PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Sensitivity is analyzed to determine the ability of each modality to accurately identify true-positive cases, validated through pathological confirmation and follow-up data.
Measured: 1 year
Specificity Comparison Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC
This study evaluates the specificity of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Specificity, defined as the ability to correctly identify true-negative cases, is validated using pathological confirmation and follow-up data to assess the diagnostic accuracy of each imaging modality.
Measured: 1year
Comparison of Overall Accuracy Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC
This study compares the overall accuracy of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Overall accuracy is defined as the proportion of correct results (both true positives and true negatives) among all the cases, validated by pathological confirmation and follow-up data to assess the diagnostic effectiveness of each imaging modality.
Measured: 1 year
Secondary outcomes (1)
Comparison of Examination Costs Between PET/MRI and PET/CT in NPC Staging
This study compares the examination costs of PET/MRI and PET/CT in staging nasopharyngeal carcinoma (NPC). The analysis includes the direct costs associated with each imaging modality, such as equipment, personnel, and operational expenses, to evaluate the cost-effectiveness of both techniques in clinical practice.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nuclear MedicineStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947759
- Sponsor's protocol ID
- CF25181A
- Other IDs
- TCVGH-1142401F
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feng Q, Liang J, Wang L, Ge X, Ding Z, Wu H. A diagnosis model in nasopharyngeal carcinoma based on PET/MRI radiomics and semiquantitative parameters. BMC Med Imaging. 2022 Aug 29;22(1):150. doi: 10.1186/s12880-022-00883-6.
PubMed 36038819Fang Y, Chen S, Xu Y, Qiang M, Tao C, Huang S, Wang L, Chen X, Cao C. Assessment of bone lesions with 18 F-FDG PET/MRI in patients with nasopharyngeal carcinoma. Nucl Med Commun. 2023 Jun 1;44(6):457-462. doi: 10.1097/MNM.0000000000001682. Epub 2023 Mar 10.
PubMed 36897049Cao C, Fang Y, Yu B, Xu Y, Qiang M, Tao C, Huang S, Chen X. Use of 18F-FDG PET/MRI as an Initial Staging Procedure for Nasopharyngeal Carcinoma. J Magn Reson Imaging. 2024 Mar;59(3):922-928. doi: 10.1002/jmri.28842. Epub 2023 May 31.
PubMed 37256732
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 18F-FDG PET/MRI as an Initial Staging Procedure for Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06947759
- Acronym / sponsor ID
- CF25181A
- Conditions
- Nuclear Medicine, Oncology
- Keywords
- PET/MRI, Nasopharyngeal carcinoma, EBV DNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Apr 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.
This single-center prospective observational study aims to evaluate the feasibility, cost-effectiveness, and clinical value of positron emission tomography/magnetic resonance imaging (PET/MRI) for initial staging in patients with locally advanced nasopharyngeal carcinoma (NPC). It will compare the diagnostic performance of PET/MRI, including sensitivity, specificity, and staging accuracy, with traditional staging methods such as positron emission tomography/computed tomography (PET/CT).
Nasopharyngeal carcinoma is prevalent in Southeast Asia and North Africa, with approximately 5% of newly diagnosed cases presenting with distant metastases. For patients with N2-3 disease and elevated Epstein-Barr virus (EBV) DNA levels, the risk of distant metastasis can reach 27.5%. Accurate detection of distant metastases at diagnosis is crucial for staging and treatment planning. Current National Comprehensive Cancer Network (NCCN) guidelines recommend fluorodeoxyglucose (18F-FDG) PET/CT for staging in locally advanced nasopharyngeal carcinoma, as traditional tools (e.g., chest CT, abdominal ultrasound, bone scans) may yield false-negative results.
PET/MRI, as a novel imaging technique, offers potential advantages such as improved diagnostic accuracy, shorter scan times, and reduced false-positive rates. However, its clinical application is limited by high costs and equipment availability. This study will explore the clinical value and economic feasibility of PET/MRI in nasopharyngeal carcinoma staging, aiming to establish its potential role in improving diagnostic pathways.
Detailed description
- Background: Nasopharyngeal carcinoma (NPC) is prevalent in Southeast Asia and North Africa, with 5% of newly diagnosed cases showing distant metastases. For N2-3 stage patients with high Epstein-Barr virus (EBV) DNA levels, the metastasis rate can reach 27.5%. Accurate detection at diagnosis is crucial for staging and treatment planning. While the National Comprehensive Cancer Network (NCCN) recommends fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for staging locally advanced NPC, traditional methods like chest CT or ultrasound may yield false negatives. PET/MRI offers improved accuracy and reduced false positives but is limited by high costs and low accessibility. This study examines the cost-effectiveness and clinical value of PET/MRI in NPC staging.
- Material and methods: This study is a single-center prospective observational study. It will recruit patients aged 18 years or older with pathologically confirmed nasopharyngeal carcinoma (NPC) who have not received any NPC-related treatment and agree to participate. All participants will undergo PET/CT and PET/MRI to compare their diagnostic performance in detecting distant metastases, including sensitivity, specificity, and staging accuracy. The study will also evaluate the time efficiency and cost-effectiveness of PET/MRI to explore its clinical value and limitations.
- Expecting Results:
This study aims to demonstrate that PET/MRI has superior diagnostic accuracy over PET/CT in staging locally advanced nasopharyngeal carcinoma, especially in detecting distant metastases. Despite higher costs, PET/MRI's accuracy may streamline diagnosis, reduce unnecessary tests, and support precise treatment strategies, improving patient outcomes and quality of life. The results will provide evidence for its clinical use and guide future diagnostic improvements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants in this study are pathologically diagnosed nasopharyngeal carcinoma (NPC) patients, primarily focusing on those with locally advanced staging (cT3-4/N2-N3), who have not yet received any treatment related to NPC. Participants must be 18 years or older, in good physical condition, and able to cooperate in completing imaging examinations and treatments.
Key inclusion criteria (4 listed)
- Pathologically diagnosed with nasopharyngeal carcinoma (NPC) through endoscopic biopsy at the hospital's otolaryngology department.
- Clinically staged as cT3-4/N2-N3.
- Age: 18 years and older.
- Participants must voluntarily sign an informed consent form, acknowledging understanding of the study objectives and potential risks.
Key exclusion criteria (3 listed)
- Patients with poorly controlled diabetes. -Patients with a history of head and neck malignancies or a history of non- head and neck cancers with no evidence of disease for at least 3 years.
- Patients with clinical staging of cT1-2N0-1.
- Patients with factors that may affect PET/MRI image quality, such as implanted metal devices or MRI contraindications, or those with a history of contrast agent allergies.
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 |
|---|---|---|
| PET/MRIThis single-center prospective observational study targets patients pathologically diagnosed with nasopharyngeal carcinoma (NPC) and clinically staged as cT3-4/N2-N3. Participants will first undergo standard whole-body 18F-FDG PET/CT, followed by localized 18F-FDG PET/MRI of the head and neck within 4 hours. Both imaging procedures will be performed according to standard clinical protocols to ensure data consistency and comparability. PET/MRI data will be independently interpreted by an experienced nuclear medicine physician and a radiologist. The sensitivity, specificity, and staging accuracy for detecting distant metastases will be analyzed. In cases of disagreement, a third physician will mediate to reach a consensus. The study team will also record the operational time, direct costs, and potential issues encountered during the examination process for both imaging modalities. All participants will be followed for at least one year to validate imaging results and assess correlation | Radiation | – |
Primary outcome
Sensitivity of PET/MRI vs. PET/CT in Detecting Distant Metastases in NPC
Time frame: 1 year
This study evaluates the sensitivity of PET/MRI compared to PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Sensitivity is analyzed to determine the ability of each modality to accurately identify true-positive cases, validated through pathological confirmation and follow-up data.
Specificity Comparison Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC
Time frame: 1year
This study evaluates the specificity of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Specificity, defined as the ability to correctly identify true-negative cases, is validated using pathological confirmation and follow-up data to assess the diagnostic accuracy of each imaging modality.
Comparison of Overall Accuracy Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC
Time frame: 1 year
This study compares the overall accuracy of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Overall accuracy is defined as the proportion of correct results (both true positives and true negatives) among all the cases, validated by pathological confirmation and follow-up data to assess the diagnostic effectiveness of each imaging modality.
1 secondary outcome
Comparison of Examination Costs Between PET/MRI and PET/CT in NPC Staging
Time frame: 1 year
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 27 Apr 2025.
- Results publication: PubMed 36038819Feng Q, Liang J, Wang L, Ge X, Ding Z, Wu H. A diagnosis model in nasopharyngeal carcinoma based on PET/MRI radiomics and semiquantitative parameters. BMC Med Imaging. 2022 Aug 29;22(1):150. doi: 10.1186/s12880-022-00883-6.
- Results publication: PubMed 36897049Fang Y, Chen S, Xu Y, Qiang M, Tao C, Huang S, Wang L, Chen X, Cao C. Assessment of bone lesions with 18 F-FDG PET/MRI in patients with nasopharyngeal carcinoma. Nucl Med Commun. 2023 Jun 1;44(6):457-462. doi: 10.1097/MNM.0000000000001682. Epub 2023 Mar 10.
- Results publication: PubMed 37256732Cao C, Fang Y, Yu B, Xu Y, Qiang M, Tao C, Huang S, Chen X. Use of 18F-FDG PET/MRI as an Initial Staging Procedure for Nasopharyngeal Carcinoma. J Magn Reson Imaging. 2024 Mar;59(3):922-928. doi: 10.1002/jmri.28842. Epub 2023 May 31.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nuclear Medicine and Oncology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Apr 2025. 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 Taiwan. 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?
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 Yi-Chun Liu, MD (886-4-23592525 ext. 5601, b9202080@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of PET/MRI vs. PET/CT in Detecting Distant Metastases in NPC (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT06947759, which also lists 3 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 27 Apr 2025.