Aggressive Lymphoma
Conditions
Brief summary
This multicenter study aims to evaluate the predictive value of tumor microenvironment PET/CT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET/CT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET/CT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.
Interventions
DRUGAl18F-NOTA-FAPI
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans
DRUGAl18F-NOTA-grazytracer/68Ga-grazytracer
Al18F-NOTA-grazytracer/68Ga-grazytracer was injected into the patients before the PET/CT scans
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed aggressive lymphoma. * Baseline PET/CT showing moderate to high FDG uptake in lymphoma lesions. * No previous history of malignant tumors. * No significant cardiac, hepatic, or renal dysfunction. * Expected survival of at least 6 months and ability to complete follow-up.
Exclusion criteria
* Low FDG uptake on baseline PET/CT. * Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation. * Active or uncontrolled chronic inflammation or infection. * Uncontrolled diabetes mellitus. * Incomplete clinical data or loss to follow-up. * Refusal to sign the informed consent form. * Inability to lie supine for 30 minutes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression | Every 3 months after enrollment for up to 2 years | The predictive performance of FAPI PET/CT imaging parameters for treatment response or disease progression in patients with aggressive lymphoma will be evaluated. Imaging parameters, including visual assessment and semi-quantitative parameters such as SUVmax, tumor-to-background ratios, metabolic tumor volume, total lesion glycolysis, and SUV heterogeneity, will be analyzed using receiver operating characteristic curve analysis. The area under the curve, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated. |
Countries
China
Contacts
CONTACTXin Liu, M.D.
STUDY_CHAIRXuejuan Wang, M.D.
Chinese Academy of Medical Sciences
Outcome results
None listed