PET/MR in Locally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT03657017

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2025-12-30

Brief Summary

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PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma PET/MR

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET/MR

Patients are examined with PET/MR.

Group Type OTHER

PET/MR

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaozhong

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Caineng Cao, MD

Role: CONTACT

0571-88128202

Facility Contacts

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Xiaozhong Chen, MD

Role: primary

+86-571-88128202

Other Identifiers

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PET/MR-2018-01

Identifier Type: -

Identifier Source: org_study_id

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