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Clinical Trials in China / NCT07657494
Recruiting Not applicable

Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma

NCT07657494 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Not applicable
Started
2024-07-11
Last updated
2026-10-07

Condition(s) studied

Aggressive Lymphoma

Investigational drug(s) / intervention(s)

Al18F-NOTA-FAPIAl18F-NOTA-grazytracer/68Ga-grazytracer

Al18F-NOTA-FAPI: Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans

Al18F-NOTA-grazytracer/68Ga-grazytracer: Al18F-NOTA-grazytracer/68Ga-grazytracer was injected into the patients before the PET/CT scans

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Chao Yang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07657494 on ClinicalTrials.gov ↗ ← All trials in China