Nasopharyngeal CarcinomaNCT04394065
uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- ultrasensitive positron emission tomography
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 20 Jun 2021
- How long will I take part?
- 1 Year
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: newly diagnosed NPC
Who may be able to join
- Patients must be informed of the investigational nature of this study and given written informed consent.
- Aged between 18-65, male/female.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III)..
- Fertile women should practice contraception during the study period.
- HGB ≥90g/L ,WBC ≥4*109/L , PLT ≥100*109/L,
- With normal liver function test (ALT and AST ≤2.5*ULN, TBil ≤2.0*ULN)
- With normal renal function test (serum creatinine ≤1.5*ULN)
Who cannot join
- Women in pregnancy or lactation
- Patients with diabetes
- Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- Already involved in other clinical trial.
- Mental disorder, civil disability, limited capacity for civil conduct.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT
uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma
Read the detailed description
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- ultrasensitive positron emission tomography
- Keywords
- ultrasensitive PET CT
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasensitive positron emission tomographyDevice
Also called conventional PET/CT
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)
| Study group | Role | What they receive |
|---|---|---|
| uEXPLORER total-body PET/CT | Newly diagnosed NPC patients will undergo a one-hour total-body dynamic PET/CT examination and subsequently followed by a conventional PET/CT scan within 30 minutes Receives: Device: ultrasensitive positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of uEXPLORER Total-body PET/CT
The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT
Measured: 6 months
Secondary outcomes (2)
Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT
Image quality and Static Lesion detectability of TB-PET/CT and conventional PET/CT
Measured: 6 months
Protocol of TB-PET/CT in NPC
Acquisition time and low dose simulation of TB-PET/CT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Jun 2020
- Primary completion20 Feb 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 56 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
- Investigators
- Haiqiang Mai, Dr, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394065
- Sponsor's protocol ID
- 2020-5-13 high-sensitivity PET
- Status last verified
- Sep 2021
- First submitted
- 12 May 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.
PubMed 31964808Lv Y, Lv X, Liu W, Judenhofer MS, Zwingenberger A, Wisner E, Berg E, McKenney S, Leung E, Spencer BA, Cherry SR, Badawi RD. Mini EXPLORER II: a prototype high-sensitivity PET/CT scanner for companion animal whole body and human brain scanning. Phys Med Biol. 2019 Mar 21;64(7):075004. doi: 10.1088/1361-6560/aafc6c.
PubMed 30620929
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT
- ClinicalTrials.gov ID
- NCT04394065
- Acronym / sponsor ID
- 2020-5-13 high-sensitivity PET
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- ultrasensitive PET CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 19 May 2020 (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.
uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma
Detailed description
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uEXPLORER total-body PET/CT | – | Device: ultrasensitive positron emission tomographyNewly diagnosed NPC patients will undergo a one-hour total-body dynamic PET/CT examination and subsequently followed by a conventional PET/CT scan within 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed NPC
Key inclusion criteria (7 listed)
- Patients must be informed of the investigational nature of this study and given written informed consent.
- Aged between 18-65, male/female.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III)..
- Fertile women should practice contraception during the study period.
- HGB ≥90g/L ,WBC ≥4*109/L , PLT ≥100*109/L,
Key exclusion criteria (6 listed)
- Women in pregnancy or lactation
- Patients with diabetes
- Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- Already involved in other clinical trial.
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 |
|---|---|---|
| ultrasensitive positron emission tomographyAlso: conventional PET/CTA 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER) | Device | uEXPLORER total-body PET/CT |
Primary outcome
The results of uEXPLORER Total-body PET/CT
Time frame: 6 months
The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT
2 secondary outcomes
Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT
Time frame: 6 months
Protocol of TB-PET/CT in NPC
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 31964808Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.
- Results publication: PubMed 30620929Lv Y, Lv X, Liu W, Judenhofer MS, Zwingenberger A, Wisner E, Berg E, McKenney S, Leung E, Spencer BA, Cherry SR, Badawi RD. Mini EXPLORER II: a prototype high-sensitivity PET/CT scanner for companion animal whole body and human brain scanning. Phys Med Biol. 2019 Mar 21;64(7):075004. doi: 10.1088/1361-6560/aafc6c.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal 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
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic 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. This study is not recruiting at the moment.
Haiqiang Mai, Dr principal investigator
Sun Yat-sen University
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 Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 17 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The results of uEXPLORER Total-body PET/CT (time frame: 6 months). 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 NCT04394065, 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 17 Sep 2021.