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

NCT07657494 | Recruiting

• 1 other identifier: NCC012236
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Aggressive Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  Every 3 months after enrollment for up to 2 years

Study Arms (1)

Tumor Microenvironment PET/CT Imaging

EXPERIMENTAL

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.

Drug: Al18F-NOTA-FAPI; Drug: Al18F-NOTA-grazytracer/68Ga-grazytracer

Interventions

Al18F-NOTA-FAPI DRUG

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

Tumor Microenvironment PET/CT Imaging

Al18F-NOTA-grazytracer/68Ga-grazytracer DRUG

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

Tumor Microenvironment PET/CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Chao Yang, 100021, China

RECRUITING

Study Officials

• Xuejuan Wang, M.D.

  Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Xin Liu, M.D.

CONTACT

15621479631; liux0077@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: July 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)