68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

Peking University Cancer Hospital & Institute24 enrolled

Overview

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.

The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

68Ga-grazytracerDRUG

68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants who were diagnosed with malignant tumors; 2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team; 3. participants who had no prior immunotherapy; 4. participants who had no regional therapy within 3 months; 5. Participants aged ≥18 years. Exclusion Criteria: 1. participants with a concurrent disease that would impede the treatment regimen; 2. Participants who were unable or unwilling to provide written informed consent.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Incidence of 68Ga-grazytracer-emergent Adverse Events

Any adverse events following the administration of the radiotracer will be monitored.

Time frame: 3 year

Biodistribution of 68Ga-grazytracer

The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.

Time frame: 3 year

Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer

The specificity of 68Ga-grazytracer will be validated by correlating the immunohistochemistry results of granzyme B in either surgical or biopsy tissue samples with the standardized uptake values (SUV) of 68Ga-grazytracer in the tumors.

Time frame: 3 year

Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response

Participants will be categorized into groups with high or low 68Ga-grazytracer uptake in tumor lesions. The progression-free survival and treatment response, as assessed by RECIST 1.1 criteria, will be compared across these groups.

Time frame: 3 year

Secondary Outcomes

Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype

Participants' tumors will be classified as either "desert" or "non-desert" based on immunohistochemistry staining of CD8 from tumor samples. Subsequently, the relationship between 68Ga-grazytracer uptake and the tumors' immune phenotype will be compared.

Time frame: 3 year

Data from ClinicalTrials.gov

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