Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma

NCT02931201 | Unknown

• 1 other identifier: XW-DLBCL-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 DLBCL.

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Positron-Emission Tomography; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 2 year progression-free survival

  up to 2 years after initial diagnosis

Study Arms (1)

DLBCL patients with 18F-FDG PET/CT

EXPERIMENTAL

18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria

Device: 18F-FDG PET/CT

Interventions

18F-FDG PET/CT DEVICE

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).

DLBCL patients with 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed DLBCL
• treated using an anthracycline-containing regimen with or without rituximab
• minimal follow-up at 6 months after the completion of first-line treatment
• complete medical history and clinicopathological data

You may not qualify if:

• secondary malignant disease
• serious infection or inflammation (e.g., HIV)
• primary central nervous system lymphoma
• hepatic or renal dysfunction.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xuejuan Wang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejuan Wang, MD

CONTACT

86 10-88196364; xuejuan_wang@hotmail.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: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)