Clinical trial · Interventional
Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study
The Predictive Value of Tumor Microenvironment PET/CT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Lymphoma | Aggressive Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Al18F-NOTA-FAPI | Drug | — | UNRESOLVED |
| Al18F-NOTA-grazytracer/68Ga-grazytracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Microenvironment PET/CT Imaging
- description
- Participants with aggressive lymphoma will undergo tumor microenvironment PET/CT imaging, including FAPI PET/CT. Participants who are candidates for immunotherapy may also undergo Grazytracer PET/CT. Imaging parameters will be analyzed to evaluate their predictive value for treatment response and prognosis.
- interventionNames
- Drug: Al18F-NOTA-FAPI
- Drug: Al18F-NOTA-grazytracer/68Ga-grazytracer
Primary outcomes (1)
- measure
- Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression
- timeFrame
- Every 3 months after enrollment for up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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