PET/MR in Locally Advanced Nasopharyngeal Carcinoma

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03657017
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 91
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma; PET/MR	Diagnostic Test: PET/MR	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PET/MR in Locally Advanced Nasopharyngeal Carcinoma
• Actual Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 >4109/L, HGB>80G/L, and PLT>100109/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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiaozhong Chen	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chen Xiaozhong, Clinical Professor, Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03657017
• Other Study ID Numbers: PET/MR-2018-01
• First Posted: Sep 4, 2018
• Last Update Posted: Sep 4, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Nasopharyngeal Carcinoma

Study Results

No Results Posted as of Sep 4, 2018