PET/MR in Locally Advanced Nasopharyngeal Carcinoma

NCT03657017 | Unknown

• 1 other identifier: PET/MR-2018-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma; PET/MR

Outcome Measures

Primary Outcomes (1)

• Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma

  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 Outcomes (1)

• Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma

  about 4 years (all of patients complete treatment)

Study Arms (1)

PET/MR

OTHER

Patients are examined with PET/MR.

Diagnostic Test: PET/MR

Interventions

PET/MR 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.

PET/MR

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Caineng Cao, MD

CONTACT

0571-88128202; caocaineng777@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 4, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: December 30, 2025
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)