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NCT Number: NCT05000372

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

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.

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Key information

Conditions

Cancer Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipodystrophy Lipodystrophy, Congenital Generalized Metabolic Diseases Metabolism, Inborn Errors Neoplasms Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who were diagnosed with malignant tumors;
  • Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
  • participants who had no prior immunotherapy;
  • participants who had no regional therapy within 3 months;
  • Participants aged ≥18 years.

Exclusion criteria

  • participants with a concurrent disease that would impede the treatment regimen;
  • Participants who were unable or unwilling to provide written informed consent.

Treatment and study plan

68Ga-grazytracer

Drug

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.

Primary outcomes

  1. Incidence of 68Ga-grazytracer-emergent Adverse Events

    Time frame: 3 year

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

  2. Biodistribution of 68Ga-grazytracer

    Time frame: 3 year

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

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

    Time frame: 3 year

    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.

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

    Time frame: 3 year

    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.

Secondary outcomes

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

    Time frame: 3 year

    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.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Peking University Health Science Center

Registry information

Official study title

68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2021
Registry last updated
Dec 4, 2024

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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