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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03657017
Other study ID # PET/MR-2018-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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