The Value of PET Imaging Targeting Granzyme B in Predicting Efficacy and Prognosis in T-NK Cell Lymphoma

NCT06863441 | Not Yet Recruiting DMC

• 1 other identifier: RuijinH 2025-34
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study on the value of PET imaging targeting granzyme B in predicting the efficacy and prognosis of T-NK cell lymphoma.

Conditions

T-NK Cell Lymphoma

Keywords

PET/CT; Granzyme B; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value (SUV)

  SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions

  Baseline and 7-10 days after treatment

Secondary Outcomes (2)

• Progress free suivival

  3 years

• Overall survival

  3 years

Study Arms (1)

patients diagnosed with T-NK cell lymphoma who will receive immunotherapy

Eligibility Criteria

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

Study Population

Chinese patient with pathologically confirmed T-NK cell lymphoma

You may qualify if:

• Age \> 18 years, regardless of gender.
• Histopathologically confirmed diagnosis of T-NK cell lymphoma.
• Newly diagnosed and untreated patients or refractory/relapsed patients preparing to undergo immunotherapy.
• Availability of complete clinicopathological and follow-up data.
• Signed and dated informed consent form.

You may not qualify if:

• Patients who have previously received anti-tumor therapy.
• Patients with a history of other malignancies.
• Incomplete clinical information or imaging data.
• Concurrent other malignant tumors.
• Patients with severe medical conditions deemed unsuitable for participation in this clinical study by the investigator, such as severe cardiopulmonary insufficiency or severe hepatic and renal dysfunction.
• Poor compliance.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School, Shanghai

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell; Lipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Xinyu Zhang

CONTACT

15958022176; zhangxinyu76@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)