LymphomaNCT06795113
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
An observational study of Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
To develop a novel method for evaluating treatment response in lymphoma by utilizing PET/CT imaging data from patients with high-metabolic lymphoma. This involves comparing end-of-treatment PET (EOT-PET) with interim PET (iPET) results to establish a new response assessment approach. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lymphoma
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2013to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with high-metabolic lymphoma
Who may be able to join
- Histopathologically confirmed high-metabolic lymphoma
- Underwent 18F-FDG PET/CT imaging before, during, and after treatment
- Treated with a standard first-line therapeutic regimen according to lymphoma treatment guidelines and individualized patient-specific considerations
- Complete clinicopathological and follow-up data available Exclusion Criteria
- 1: History of prior antitumor treatment 2: History of other malignancies 3: Incomplete clinical data or imaging records 4: Presence of other concurrent malignant tumors
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality
Yena Hong, 18258061927, hongyn28@outlook.com
About this study
To develop a novel method for evaluating treatment response in lymphoma by utilizing PET/CT imaging data from patients with high-metabolic lymphoma. This involves comparing end-of-treatment PET (EOT-PET) with interim PET (iPET) results to establish a new response assessment approach. The aim is to contrast this method with the Lugano classification criteria, providing clinicians with more scientific and accurate tools for response evaluation and prognosis prediction.
Read the detailed description
This study adopted a multicenter retrospective cohort design. A total of 2,000 patients with highly metabolic lymphoma who underwent PET/CT scans and had clinical data available at Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, from June 2013 to December 2023, were selected for model development. The model was validated using an external validation cohort of 2,000 patients with highly metabolic lymphoma who underwent PET/CT scans at other institutions, including West China Hospital of Sichuan University. All patients were required to have undergone 18F-FDG PET/CT scans before treatment, during treatment, and after treatment.
Lesions were manually delineated, and software was used to automatically calculate PET/CT parameters such as SUVmax, metabolic tumor volume (MTV), and total lesion glycolysis (TLG) for primary and metastatic lesions based on 18F-FDG PET/CT. Clinical data for all patients were collected from their medical records, including age, gender, LDH levels, B symptoms, extranodal involvement, IPI score, presence of bulky disease, pathological subtype, and treatment regimen.
Each patient's end-of-treatment PET/CT was compared with baseline PET/CT based on the Lugano criteria to evaluate treatment response, and the results were recorded in Group A. Correspondingly, the end-of-treatment PET/CT was also compared with interim PET/CT to derive a new treatment response evaluation, and the results were recorded in Group B. The treatment response evaluations from Groups A and B were then compared. Statistical analysis was performed to identify patients with inconsistent treatment response evaluations between the two groups. Additionally, it was recorded whether the treatment plan for each patient was altered at the end of first-line therapy based on the treatment response evaluation from Group B.
- Conditions
- Lymphoma
- Keywords
- PET/CT, lymphoma, 18F-FDG
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Modeling group, 2000 patients | clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans. | |
| Validation group, 2000 patients | clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
Measured: Before the start of treatment, after 4 cycles of treatment(each cycle is 28 days), and 6-8 weeks after the end of treatment.
Secondary outcomes (1)
Progression-Free Survival
Progression-Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jun 2013
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, West China Hospital
- Responsible party
- Principal investigator, GUO RUI, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795113
- Sponsor's protocol ID
- RuijinH 2025-1
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
- ClinicalTrials.gov ID
- NCT06795113
- Acronym / sponsor ID
- RuijinH 2025-1
- Conditions
- Lymphoma
- Keywords
- PET/CT, lymphoma, 18F-FDG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, West China Hospital
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop a novel method for evaluating treatment response in lymphoma by utilizing PET/CT imaging data from patients with high-metabolic lymphoma. This involves comparing end-of-treatment PET (EOT-PET) with interim PET (iPET) results to establish a new response assessment approach. The aim is to contrast this method with the Lugano classification criteria, providing clinicians with more scientific and accurate tools for response evaluation and prognosis prediction.
Detailed description
This study adopted a multicenter retrospective cohort design. A total of 2,000 patients with highly metabolic lymphoma who underwent PET/CT scans and had clinical data available at Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, from June 2013 to December 2023, were selected for model development. The model was validated using an external validation cohort of 2,000 patients with highly metabolic lymphoma who underwent PET/CT scans at other institutions, including West China Hospital of Sichuan University. All patients were required to have undergone 18F-FDG PET/CT scans before treatment, during treatment, and after treatment.
Lesions were manually delineated, and software was used to automatically calculate PET/CT parameters such as SUVmax, metabolic tumor volume (MTV), and total lesion glycolysis (TLG) for primary and metastatic lesions based on 18F-FDG PET/CT. Clinical data for all patients were collected from their medical records, including age, gender, LDH levels, B symptoms, extranodal involvement, IPI score, presence of bulky disease, pathological subtype, and treatment regimen.
Each patient's end-of-treatment PET/CT was compared with baseline PET/CT based on the Lugano criteria to evaluate treatment response, and the results were recorded in Group A. Correspondingly, the end-of-treatment PET/CT was also compared with interim PET/CT to derive a new treatment response evaluation, and the results were recorded in Group B. The treatment response evaluations from Groups A and B were then compared. Statistical analysis was performed to identify patients with inconsistent treatment response evaluations between the two groups. Additionally, it was recorded whether the treatment plan for each patient was altered at the end of first-line therapy based on the treatment response evaluation from Group B.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling group, 2000 patients | – | –clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans. |
| Validation group, 2000 patients | – | –clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with high-metabolic lymphoma
Key inclusion criteria (5 listed)
- Histopathologically confirmed high-metabolic lymphoma
- Underwent 18F-FDG PET/CT imaging before, during, and after treatment
- Treated with a standard first-line therapeutic regimen according to lymphoma treatment guidelines and individualized patient-specific considerations
- Complete clinicopathological and follow-up data available Exclusion Criteria
- 1: History of prior antitumor treatment 2: History of other malignancies 3: Incomplete clinical data or imaging records 4: Presence of other concurrent malignant tumors
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
Time frame: Before the start of treatment, after 4 cycles of treatment(each cycle is 28 days), and 6-8 weeks after the end of treatment.
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma
1 secondary outcome
Progression-Free Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- 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.
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, run by Ruijin Hospital 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Guo (13361860108, gr11734@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma (time frame: Before the start of treatment, after 4 cycles of treatment(each cycle is 28 days), and 6-8 weeks after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.