CClinicalTrials.gg
Status unknownNCT02931201Updated Oct 12, 2016

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

An interventional study of 18F-FDG PET/CT in Lymphoma, Large B-Cell, Diffuse, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by Peking University Cancer Hospital & Institute · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed 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 (1.6 fold of liver SUVmax) 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 DLBCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

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Conditions studied

  • Lymphoma, Large B-Cell, Diffuse

Keywords

  • Positron-Emission Tomography
  • Prognosis
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    DLBCL patients with 18F-FDG PET/CT

    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

  • Device18F-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).

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What researchers measure

Primary outcomes

  1. Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles

    Time frame: 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

    Time frame: up to 2 years after initial diagnosis

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02931201
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Xuejuan Wang,MD (Principal Investigator, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
Oct 12, 2016
Start date
Oct 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Oct 12, 2016

Study contacts

Xuejuan Wang, MD
Contact
xuejuan_wang@hotmail.com
86 10-88196364
Xuejuan Wang, MD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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