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

Cancer Clinical Trial

Official title:

68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects With Non-small Cell Lung Cancer, Melanoma or Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000372
• Other study ID #: 2021KT86
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 22, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Haoyi Zhou
• Phone: +8610-82802893
• Email: 2011110024[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 non-small cell lung cancer, melanoma or lymphoma receiving immunotherapy.

Description:

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 non-small cell lung cancer, melanoma and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 68Ga-grazytracer
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute	Peking University Health Science Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of 68Ga-grazytracer-emergent Adverse Events	Any adverse events following the administration of the radiotracer will be monitored.	3 year
Primary	Biodistribution of 68Ga-grazytracer	The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.	3 year
Primary	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.	3 year
Primary	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.	3 year
Secondary	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.	3 year