18F-FDG PET Radiomics of Diffuse Large B-cell Lymphoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04317313
Collaborator
(none)
152
Enrollment
1
Location
15.9
Actual Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the prognostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) radiomics in diffuse large B-cell lymphoma (DLBCL) and its additional value to the International Prognostic Index (IPI).

Condition or DiseaseIntervention/TreatmentPhase
  • Other: FDG PET radiomic feature evaluation

Detailed Description

Several studies have shown that 18F-FDG PET radiomics is predictive of survival in DLBCL. However, to the best of the investigator's knowledge, a multi-feature radiomic signature for prognosis assessment of DLBCL has not yet been described. Furthermore, it remains unclear whether PET-based radiomics could add more prognostic values to the IPI in DLBCL.

This study aims to develop 18F-FDG PET radiomic signature, and investigate whether the radiomic signature could improve the prognostic value of the IPI score in predicting progression-free survival (PFS) and overall survival (OS) in DLBCL.

Study Design

Study Type:
Observational
Actual Enrollment :
152 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Synergistic Effect of 18F-FDG PET Radiomics and International Prognostic Index on Outcome Prediction in Diffuse Large B-cell Lymphoma
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years]

    the period from the initial diagnosis to the death from any cause

  2. Progression-free Survival [From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years]

    the period from the initial diagnosis to the progression, relapse or death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. histopathologically confirmed diffuse large B-cell lymphoma (DLBCL);

  2. Over 18 years old when diagnosed;

  3. Have undergone pre-treatment 18F-FDG PET/CT;

  4. Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).

Exclusion Criteria:
  1. Have primary central nervous system (CNS) lymphoma or second primary cancer;

  2. Have undergone surgical resection;

  3. With an incomplete follow-up.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhouZhejiangChina310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Mei Tian, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04317313
Other Study ID Numbers:
  • 2019-350
First Posted:
Mar 23, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleTraining CohortValidation Cohort
Arm/Group DescriptionPatients diagnosed between July 2013 and March 2017. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg).Patients diagnosed between April 2017 and July 2019. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg).
Period Title: Overall Study
STARTED10052
COMPLETED10052
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleTraining CohortValidation CohortTotal
Arm/Group DescriptionPatients diagnosed between July 2013 and March 2017Patients diagnosed between April 2017 and July 2019Total of all reporting groups
Overall Participants10052152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
57.8
(14.6)
59.4
(15.7)
58.3
(14.9)
Sex: Female, Male (Count of Participants)
Female
52
52%
24
46.2%
76
50%
Male
48
48%
28
53.8%
76
50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
China
100
100%
52
100%
152
100%
lactate dehydrogenase (Count of Participants)
Normal
45
45%
21
40.4%
66
43.4%
Elevated
55
55%
31
59.6%
86
56.6%
β2-microglobulin (Count of Participants)
Normal
67
67%
31
59.6%
98
64.5%
Elevated
33
33%
21
40.4%
54
35.5%
Ann Arbor stage (Count of Participants)
Ⅰ-Ⅱ
38
38%
15
28.8%
53
34.9%
Ⅲ-Ⅳ
62
62%
37
71.2%
99
65.1%
Performance status (Count of Participants)
< 2
76
76%
32
61.5%
108
71.1%
≥ 2
24
24%
20
38.5%
44
28.9%
B symptoms (Count of Participants)
Yes
28
28%
20
38.5%
48
31.6%
No
72
72%
32
61.5%
104
68.4%
Extranodal sites (Count of Participants)
< 2
71
71%
30
57.7%
101
66.4%
≥ 2
29
29%
22
42.3%
51
33.6%
International Prognostic Index (Count of Participants)
≤ 2
54
54%
30
57.7%
84
55.3%
> 2
46
46%
22
42.3%
68
44.7%
Cell of origin (Count of Participants)
germinal center B-cell like
28
28%
14
26.9%
42
27.6%
non-germinal center B-cell like
72
72%
38
73.1%
110
72.4%
Treatment (Count of Participants)
Chemotherapy alone
72
72%
41
78.8%
113
74.3%
Chemotherapy + radiotherapy
25
25%
10
19.2%
35
23%
Chemotherapy + autologous stem cell transplantation
3
3%
1
1.9%
4
2.6%
Chemotherapy regimens (Count of Participants)
R-CHOP
95
95%
48
92.3%
143
94.1%
R-EPOCH
5
5%
4
7.7%
9
5.9%

Outcome Measures

1. Primary Outcome
TitleOverall Survival
Descriptionthe period from the initial diagnosis to the death from any cause
Time FrameFrom date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTraining CohortValidation Cohort
Arm/Group DescriptionPatients diagnosed between July 2013 and March 2017Patients diagnosed between April 2017 and July 2019
Measure Participants10052
Median (Full Range) [months]
56
29
2. Primary Outcome
TitleProgression-free Survival
Descriptionthe period from the initial diagnosis to the progression, relapse or death from any cause
Time FrameFrom date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTraining CohortValidation Cohort
Arm/Group DescriptionPatients diagnosed between July 2013 and March 2017Patients diagnosed between April 2017 and July 2019
Measure Participants10052
Median (Full Range) [months]
52.5
28

Adverse Events

Time FrameFrom patient diagnosis to the end of the study, up to 1 year
Adverse Event Reporting Description
Arm/Group TitleTraining CohortValidation Cohort
Arm/Group DescriptionPatients diagnosed between July 2013 and March 2017Patients diagnosed between April 2017 and July 2019
All Cause Mortality
Training CohortValidation Cohort
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total27/100 (27%) 14/52 (26.9%)
Serious Adverse Events
Training CohortValidation Cohort
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/100 (0%) 0/52 (0%)
Other (Not Including Serious) Adverse Events
Training CohortValidation Cohort
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/100 (0%) 0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Xiaohui Zhang
OrganizationSecond Affiliated Hospital, School of Medicine, Zhejiang University
Phone+86-571-87767188
Emailzhanghui4127@zju.edu.cn
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04317313
Other Study ID Numbers:
  • 2019-350
First Posted:
Mar 23, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
May 1, 2021