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)
• Enrollment: 152
• Location: 1
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 9.5

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 Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse	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

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009

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)

• Study Protocol and Statistical Analysis Plan - Jul 29, 2021

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: PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Study Results

Participant Flow

Arm/Group Title	Training Cohort	Validation Cohort
Arm/Group Description	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).	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
STARTED	100	52
COMPLETED	100	52
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Training Cohort	Validation Cohort	Total
Arm/Group Description	Patients diagnosed between July 2013 and March 2017	Patients diagnosed between April 2017 and July 2019	Total of all reporting groups
Overall Participants	100	52	152
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

Title	Overall Survival
Description	the period from the initial diagnosis to the death from any cause
Time Frame	From 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 Title	Training Cohort	Validation Cohort
Arm/Group Description	Patients diagnosed between July 2013 and March 2017	Patients diagnosed between April 2017 and July 2019
Measure Participants	100	52
Median (Full Range) [months]	56	29

2. Primary Outcome

Title	Progression-free Survival
Description	the period from the initial diagnosis to the progression, relapse or death from any cause
Time Frame	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Training Cohort	Validation Cohort
Arm/Group Description	Patients diagnosed between July 2013 and March 2017	Patients diagnosed between April 2017 and July 2019
Measure Participants	100	52
Median (Full Range) [months]	52.5	28

Adverse Events

Time Frame	From patient diagnosis to the end of the study, up to 1 year
Arm/Group Title	Training Cohort		Validation Cohort
Arm/Group Description	Patients diagnosed between July 2013 and March 2017		Patients diagnosed between April 2017 and July 2019
All Cause Mortality
	Training Cohort		Validation Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/100 (27%)		14/52 (26.9%)
Serious Adverse Events
	Training Cohort		Validation Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Training Cohort		Validation Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (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.