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

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03051568

Collaborator

Beijing Municipal Administration of Hospitals (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Peripheral	Device: 18F-FDG PET/CT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTCL 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 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).

Arm

Intervention/Treatment

Experimental: PTCL 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

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).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

3 year progression-free survival [up to 3 years after initial diagnosis]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

Peking University Cancer Hospital & Institute
Beijing Municipal Administration of Hospitals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuejuan Wang,MD, Principal Investigator, Peking University Cancer Hospital & Institute

ClinicalTrials.gov Identifier:

NCT03051568

Other Study ID Numbers:

XW-PTCL-001

First Posted:

Feb 13, 2017

Last Update Posted:

Feb 13, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xuejuan Wang,MD, Principal Investigator, Peking University Cancer Hospital & Institute

Lymphoma, T-Cell, Peripheral

Positron-Emission Tomography

Prognosis

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Fluorodeoxyglucose F18

Study Results

No Results Posted as of Feb 13, 2017