PET/MR in Locally Advanced Nasopharyngeal Carcinoma

August 31, 2018 updated by: Chen Xiaozhong, Zhejiang Cancer Hospital
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Xiaozhong Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PET/MR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
about 4 years (all of patients complete treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET/MR-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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