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PET/MR in Locally Advanced Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03657017
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Information provided by (Responsible Party):
Chen Xiaozhong, Zhejiang Cancer Hospital

Brief Summary:
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma PET/MR Diagnostic Test: PET/MR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients are examined with PET/MR.
Diagnostic Test: PET/MR
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma [ Time Frame: about 4 years (all of patients complete treatment) ]
    Radiomics-based prediction model of the efficiency of treatment by PET/MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03657017

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Contact: Caineng Cao, MD 0571-88128202

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China, Zhejiang
Xiaozhong Chen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    +86-571-88128202   
Sponsors and Collaborators
Zhejiang Cancer Hospital

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Responsible Party: Chen Xiaozhong, Clinical Professor, Zhejiang Cancer Hospital Identifier: NCT03657017     History of Changes
Other Study ID Numbers: PET/MR-2018-01
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases