18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02928861
• Other study ID #: XW-DLBCL-002
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2016
• Last updated: October 7, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Beijing Cancer Hospital
• Contact: Xuejuan Wang, MD
• Phone: 86 10-88196364
• Email: xuejuan_wang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of diffuse large B-cell lymphoma can predict disease progression

Description:

In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in DLBCL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. newly diagnosed DLBCL;

2. treated using an anthracycline-containing regimen with or without rituximab;

3. minimal follow-up at 6 months after the completion of first-line treatment;

4. complete medical history and clinicopathological data

Exclusion Criteria:

1. secondary malignant disease;

2. serious infection or inflammation (e.g., HIV);

3. primary central nervous system lymphoma;

4. hepatic or renal dysfunction.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

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
China	Peking University Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year progression-free survival		up to 2 years after initial diagnosis	No