Trial Outcomes & Findings for 18F-FDG PET Radiomics of Diffuse Large B-cell Lymphoma (NCT NCT04317313)
NCT ID: NCT04317313
Last Updated: 2021-10-21
Results Overview
the period from the initial diagnosis to the death from any cause
Recruitment status
COMPLETED
Target enrollment
152 participants
Primary outcome timeframe
From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
Results posted on
2021-10-21
Participant Flow
Participant milestones
| Measure |
Training Cohort
Patients 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).
|
Validation Cohort
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).
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
52
|
|
Overall Study
COMPLETED
|
100
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Training Cohort
n=100 Participants
Patients diagnosed between July 2013 and March 2017
|
Validation Cohort
n=52 Participants
Patients diagnosed between April 2017 and July 2019
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 14.6 • n=100 Participants
|
59.4 years
STANDARD_DEVIATION 15.7 • n=52 Participants
|
58.3 years
STANDARD_DEVIATION 14.9 • n=152 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=100 Participants
|
24 Participants
n=52 Participants
|
76 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=100 Participants
|
28 Participants
n=52 Participants
|
76 Participants
n=152 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
100 participants
n=100 Participants
|
52 participants
n=52 Participants
|
152 participants
n=152 Participants
|
|
lactate dehydrogenase
Normal
|
45 Participants
n=100 Participants
|
21 Participants
n=52 Participants
|
66 Participants
n=152 Participants
|
|
lactate dehydrogenase
Elevated
|
55 Participants
n=100 Participants
|
31 Participants
n=52 Participants
|
86 Participants
n=152 Participants
|
|
β2-microglobulin
Normal
|
67 Participants
n=100 Participants
|
31 Participants
n=52 Participants
|
98 Participants
n=152 Participants
|
|
β2-microglobulin
Elevated
|
33 Participants
n=100 Participants
|
21 Participants
n=52 Participants
|
54 Participants
n=152 Participants
|
|
Ann Arbor stage
Ⅰ-Ⅱ
|
38 Participants
n=100 Participants
|
15 Participants
n=52 Participants
|
53 Participants
n=152 Participants
|
|
Ann Arbor stage
Ⅲ-Ⅳ
|
62 Participants
n=100 Participants
|
37 Participants
n=52 Participants
|
99 Participants
n=152 Participants
|
|
Performance status
< 2
|
76 Participants
n=100 Participants
|
32 Participants
n=52 Participants
|
108 Participants
n=152 Participants
|
|
Performance status
≥ 2
|
24 Participants
n=100 Participants
|
20 Participants
n=52 Participants
|
44 Participants
n=152 Participants
|
|
B symptoms
Yes
|
28 Participants
n=100 Participants
|
20 Participants
n=52 Participants
|
48 Participants
n=152 Participants
|
|
B symptoms
No
|
72 Participants
n=100 Participants
|
32 Participants
n=52 Participants
|
104 Participants
n=152 Participants
|
|
Extranodal sites
< 2
|
71 Participants
n=100 Participants
|
30 Participants
n=52 Participants
|
101 Participants
n=152 Participants
|
|
Extranodal sites
≥ 2
|
29 Participants
n=100 Participants
|
22 Participants
n=52 Participants
|
51 Participants
n=152 Participants
|
|
International Prognostic Index
≤ 2
|
54 Participants
n=100 Participants
|
30 Participants
n=52 Participants
|
84 Participants
n=152 Participants
|
|
International Prognostic Index
> 2
|
46 Participants
n=100 Participants
|
22 Participants
n=52 Participants
|
68 Participants
n=152 Participants
|
|
Cell of origin
germinal center B-cell like
|
28 Participants
n=100 Participants
|
14 Participants
n=52 Participants
|
42 Participants
n=152 Participants
|
|
Cell of origin
non-germinal center B-cell like
|
72 Participants
n=100 Participants
|
38 Participants
n=52 Participants
|
110 Participants
n=152 Participants
|
|
Treatment
Chemotherapy alone
|
72 Participants
n=100 Participants
|
41 Participants
n=52 Participants
|
113 Participants
n=152 Participants
|
|
Treatment
Chemotherapy + radiotherapy
|
25 Participants
n=100 Participants
|
10 Participants
n=52 Participants
|
35 Participants
n=152 Participants
|
|
Treatment
Chemotherapy + autologous stem cell transplantation
|
3 Participants
n=100 Participants
|
1 Participants
n=52 Participants
|
4 Participants
n=152 Participants
|
|
Chemotherapy regimens
R-CHOP
|
95 Participants
n=100 Participants
|
48 Participants
n=52 Participants
|
143 Participants
n=152 Participants
|
|
Chemotherapy regimens
R-EPOCH
|
5 Participants
n=100 Participants
|
4 Participants
n=52 Participants
|
9 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 yearsthe period from the initial diagnosis to the death from any cause
Outcome measures
| Measure |
Training Cohort
n=100 Participants
Patients diagnosed between July 2013 and March 2017
|
Validation Cohort
n=52 Participants
Patients diagnosed between April 2017 and July 2019
|
|---|---|---|
|
Overall Survival
|
56 months
Interval 4.0 to 96.0
|
29 months
Interval 4.5 to 50.0
|
PRIMARY outcome
Timeframe: 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 yearsthe period from the initial diagnosis to the progression, relapse or death from any cause
Outcome measures
| Measure |
Training Cohort
n=100 Participants
Patients diagnosed between July 2013 and March 2017
|
Validation Cohort
n=52 Participants
Patients diagnosed between April 2017 and July 2019
|
|---|---|---|
|
Progression-free Survival
|
52.5 months
Interval 4.0 to 96.0
|
28 months
Interval 4.0 to 50.0
|
Adverse Events
Training Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 27 deaths
Validation Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Xiaohui Zhang
Second Affiliated Hospital, School of Medicine, Zhejiang University
Phone: +86-571-87767188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place