Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Natural Killer/T-cell Lymphoma

Lymphoma, Extranodal NK-T-Cell Clinical Trial

Official title:

Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography / Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With NK/T-cell Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03051542
• Other study ID #: XW-NK/T-001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 9, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2017
• Source: Beijing Cancer Hospital
• Contact: Xuejuan Wang, MD
• Phone: 86 10-88196364
• Email: xuejuan_wang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease progression during chemotherapy or survival in NK/T-cell lymphoma.

Description:

In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• newly diagnosed NK/T-cell lymphoma

• treated using an anthracycline-containing regimen

• minimal follow-up at 6 months after the completion of first-line treatment

• complete medical history and clinicopathological data

Exclusion Criteria:

• secondary malignant disease

• serious infection or inflammation (e.g., HIV)

• primary central nervous system lymphoma

• hepatic or renal dysfunction.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Device:
• 18F-FDG PET/CT
18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/????dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles		baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)]
Secondary	3 year progression-free survival		up to 3 years after initial diagnosis