Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Al18F-NOTA-FAPI, Al18F-NOTA-grazytracer/68Ga-grazytracer.
- Who it may be relevant to
- Registry conditions: Aggressive Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Predictive Value of Tumor Microenvironment PET/CT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study
Overview
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
- Drug Al18F-NOTA-FAPI
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans - Drug Al18F-NOTA-grazytracer/68Ga-grazytracer
Al18F-NOTA-grazytracer/68Ga-grazytracer was injected into the patients before the PET/CT scans
Primary outcome measures
- Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression [Time frame: Every 3 months after enrollment for up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Unio — Beijing
Identifiers
NCT: NCT07657494 · NCC012236