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NCT Number: NCT07657494

Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study

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.

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Key information

Conditions

Aggressive Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chao Yang, 100021, China

Location status: Recruiting

Location contact

Xin Liu, M.D.

CONTACT

[email protected]

15621479631

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Al18F-NOTA-FAPI

Drug

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

Al18F-NOTA-grazytracer/68Ga-grazytracer

Drug

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

Primary outcomes

  1. Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Liu, M.D.

CONTACT

[email protected]

15621479631

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

The Predictive Value of Tumor Microenvironment PET/CT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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