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PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, PET/MR

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PET/MR
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nasopharyngeal Carcinoma

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiaozhong ChenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET/MR

Arm Description

Patients are examined with PET/MR.

Outcomes

Primary Outcome Measures

Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma
Radiomics-based prognostic model by PET/MRI

Secondary Outcome Measures

Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma
Radiomics-based prediction model of the efficiency of treatment by PET/MRI

Full Information

First Posted
August 15, 2018
Last Updated
August 31, 2018
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03657017
Brief Title
PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Official Title
PET/MR in Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

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

5. Study Description

Brief Summary
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, PET/MR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET/MR
Arm Type
Other
Arm Description
Patients are examined with PET/MR.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR
Intervention Description
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 Measure Information:
Title
Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma
Description
Radiomics-based prognostic model by PET/MRI
Time Frame
From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years.
Secondary Outcome Measure Information:
Title
Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma
Description
Radiomics-based prediction model of the efficiency of treatment by PET/MRI
Time Frame
about 4 years (all of patients complete treatment)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caineng Cao, MD
Phone
0571-88128202
Email
caocaineng777@sina.com
Facility Information:
Facility Name
Xiaozhong Chen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
+86-571-88128202
Email
cxzfyun@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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PET/MR in Locally Advanced Nasopharyngeal Carcinoma

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