Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06795113
Enrollment
4000
Registered
2025-01-27
Start date
2013-06-01
Completion date
2029-12-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

PET/CT, lymphoma, 18F-FDG

Brief 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. 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.

Interventions

None listed

Sponsors

Qilu Hospital of Shandong University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Histopathologically confirmed high-metabolic lymphoma 2. Underwent 18F-FDG PET/CT imaging before, during, and after treatment 3. Treated with a standard first-line therapeutic regimen according to lymphoma treatment guidelines and individualized patient-specific considerations 4. 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

Design outcomes

Primary

MeasureTime frameDescription
Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism LymphomaBefore 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

Secondary

MeasureTime frameDescription
Progression-Free Survival3 yearsProgression-Free Survival

Countries

China

Contacts

Primary ContactRui Guo
gr11734@rjh.com.cn13361860108

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026