PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657017
• Other study ID #: PET/MR-2018-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: August 2018
• Source: Zhejiang Cancer Hospital
• Contact: Caineng Cao, MD
• Phone: 0571-88128202
• Email: caocaineng777[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• PET/MR

Intervention

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.

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma	Radiomics-based prediction model of the efficiency of treatment by PET/MRI	about 4 years (all of patients complete treatment)