PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Not Applicable

Recruiting

• Conditions: PET/MR; Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: PET/MR

• Registration Number: NCT03657017
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-31
• Last Update Submitted: 2018-08-31
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-04
• Primary Completion: 2022-06-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MR	PET/MR	Patients are examined with PET/MR.

Primary Outcome Measures

Name	Time	Method
Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma	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

Name	Time	Method
Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma	about 4 years (all of patients complete treatment)	Radiomics-based prediction model of the efficiency of treatment by PET/MRI

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China