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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03051568
Enrollment
80
Registered
2017-02-13
Start date
2017-03-01
Completion date
2020-12-31
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Lymphoma, T-Cell, Peripheral, Positron-Emission Tomography, Prognosis

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 PTCL.

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 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 PTCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

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).

Sponsors

Beijing Municipal Administration of Hospitals
CollaboratorOTHER_GOV
Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* newly diagnosed PTCL * 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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cyclesbaseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)

Secondary

MeasureTime frame
3 year progression-free survivalup to 3 years after initial diagnosis

Countries

China

Contacts

Primary ContactXuejuan Wang, MD
xuejuan_wang@hotmail.com86 10-88196364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026