PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Overview

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: PET/MR
    • Patients are examined with PET/MR.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang Cancer Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chen Xiaozhong, Clinical Professor – Zhejiang Cancer Hospital
  • Overall Contact(s)
    • Caineng Cao, MD, 0571-88128202, caocaineng777@sina.com

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