Nasopharyngeal CarcinomaNCT03657017
PET/MR in Locally Advanced Nasopharyngeal Carcinoma
A study testing PET/MR in people with Nasopharyngeal Carcinoma and PET/MR, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
PET/MR in Locally Advanced Nasopharyngeal Carcinoma Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, PET/MR
- What is being tested?
- PET/MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Dec 2025
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
- Renal: creatinine clearance >60ml/min
- Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
- Written informed consent
Who cannot join
- Adenocarcinoma
- Age >70
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
- 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), or emotional disturbance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaozhong Chen
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, +86-571-88128202, cxzfyun@sina.com
About this study
PET/MR in Locally Advanced Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma, PET/MR
- Being tested
- PET/MR
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDiagnostic test
Performed on a hybrid PET/MR scanner before treatment start (N = 150). Among those patients, 10 patients are examined with PET/MR in the completion of neoadjuvant chemotherapy and a follow-up scan three months after the completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PET/MR | Other | Patients are examined with PET/MR. Receives: Diagnostic Test: PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma
Radiomics-based prognostic model by PET/MRI
Measured: From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.
Secondary outcomes (1)
Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma
Radiomics-based prediction model of the efficiency of treatment by PET/MRI
Measured: about 4 years (all of patients complete treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657017
- Sponsor's protocol ID
- PET/MR-2018-01
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MR in Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03657017
- Acronym / sponsor ID
- PET/MR-2018-01
- Conditions
- Nasopharyngeal Carcinoma, PET/MR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Sep 2018 (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.
PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR | Other | Diagnostic Test: PET/MRPatients are examined with PET/MR. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
- Renal: creatinine clearance >60ml/min
Key exclusion criteria (6 listed)
- Adenocarcinoma
- Age >70
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
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/MRPerformed on a hybrid PET/MR scanner before treatment start (N = 150). Among those patients, 10 patients are examined with PET/MR in the completion of neoadjuvant chemotherapy and a follow-up scan three months after the completion of radiotherapy. | Diagnostic test | PET/MR |
Primary outcome
Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma
Time frame: From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.
Radiomics-based prognostic model by PET/MRI
1 secondary outcome
Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma
Time frame: about 4 years (all of patients complete treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR in people with Nasopharyngeal Carcinoma and PET/MR, run by Zhejiang Cancer Hospital 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: status not confirmed, as of the sponsor's last update on 4 Sep 2018. 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?
Contact Caineng Cao, MD (0571-88128202, caocaineng777@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma (time frame: From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2018.