Lymphoma, Large B-Cell, DiffuseNCT04317313

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

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, Large B-Cell, Diffuse
What is being tested?: FDG PET radiomic feature evaluation
How many people: 152 participants
Where: 1 siteChina
Study dates: 1 Apr 2020to 30 Jul 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The target study population of this retrospective study is patients with DLBCL who have undergone pre-treatment 18F-FDG PET/CT prior to the R-CHOP or R-EPOCH chemotherapy. The study will assess the relationships between PET-derived radiomic features with the patient outcome data.

Who may be able to join

histopathologically confirmed diffuse large B-cell lymphoma (DLBCL);
Over 18 years old when diagnosed;
Have undergone pre-treatment 18F-FDG PET/CT;
Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).

Who cannot join

Have primary central nervous system (CNS) lymphoma or second primary cancer;
Have undergone surgical resection;
With an incomplete follow-up.

Trial locations and contacts

1 site in 1 country.

China1 site

Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Synergistic Effect of 18F-FDG PET Radiomics and International Prognostic Index on Outcome Prediction in Diffuse Large B-cell Lymphoma

Read the 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.

Conditions: Lymphoma, Large B-Cell, Diffuse
Being tested: FDG PET radiomic feature evaluation
Keywords: PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;
Medical subject headings: Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FDG PET radiomic feature evaluationOther
A total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features.
In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature.

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
the period from the initial diagnosis to the death from any cause
Measured: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
Progression-free Survival
the period from the initial diagnosis to the progression, relapse or death from any cause
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202030 Jul 2021

First posted23 Mar 2020
Study start1 Apr 2020
Primary completion30 Jul 2021
Study completion30 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04317313
Sponsor's protocol ID: 2019-350
Status last verified: May 2021
First submitted: 16 Mar 2020
Last updated: 21 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang X, Chen L, Jiang H, He X, Feng L, Ni M, Ma M, Wang J, Zhang T, Wu S, Zhou R, Jin C, Zhang K, Qian W, Chen Z, Zhuo C, Zhang H, Tian M. A novel analytic approach for outcome prediction in diffuse large B-cell lymphoma by [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1298-1310. doi: 10.1007/s00259-021-05572-0. Epub 2021 Oct 15.
PubMed 34651227

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synergistic Effect of 18F-FDG PET Radiomics and International Prognostic Index on Outcome Prediction in Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT04317313
Acronym / sponsor ID: 2019-350
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;
Study type: Observational
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 1 Apr 2020 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 23 Mar 2020 (actual)
Results: Posted 25 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The target study population of this retrospective study is patients with DLBCL who have undergone pre-treatment 18F-FDG PET/CT prior to the R-CHOP or R-EPOCH chemotherapy. The study will assess the relationships between PET-derived radiomic features with the patient outcome data.

Key inclusion criteria (4 listed)

histopathologically confirmed diffuse large B-cell lymphoma (DLBCL);
Over 18 years old when diagnosed;
Have undergone pre-treatment 18F-FDG PET/CT;
Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).

Key exclusion criteria (3 listed)

Have primary central nervous system (CNS) lymphoma or second primary cancer;
Have undergone surgical resection;
With an incomplete follow-up.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FDG PET radiomic feature evaluationA total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features. In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature.	Other	–

Primary outcome

Overall Survival
Time frame: 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
Progression-free Survival
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
the period from the initial diagnosis to the progression, relapse or death from any cause

Results and safety

Results posted to the registry on 25 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Training Cohort	100	100
Validation Cohort	52	52

Primary outcome: Overall Survival

Time frame: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years. Median (Full Range). Unit: months

Measure	Training Cohort n = 100	Validation Cohort n = 52
Value	56 (4 to 96)	29 (4.5 to 50)

Primary outcome: Progression-free Survival

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. Median (Full Range). Unit: months

Measure	Training Cohort n = 100	Validation Cohort n = 52
Value	52.5 (4 to 96)	28 (4 to 50)

Adverse events

Time frame: From patient diagnosis to the end of the study, up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Training Cohort	0 of 100 (0%)	0 of 100 (0%)	27 of 100
Validation Cohort	0 of 52 (0%)	0 of 52 (0%)	14 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34651227Zhang X, Chen L, Jiang H, He X, Feng L, Ni M, Ma M, Wang J, Zhang T, Wu S, Zhou R, Jin C, Zhang K, Qian W, Chen Z, Zhuo C, Zhang H, Tian M. A novel analytic approach for outcome prediction in diffuse large B-cell lymphoma by [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1298-1310. doi: 10.1007/s00259-021-05572-0. Epub 2021 Oct 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mei Tian, M.D. study director

Second Affiliated Hospital, Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Large B-Cell, Diffuse, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317313, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.