68Ga-grazytracer PET/CT in Subjects With Non-small Cell Lung Cancer or Melanoma

Study Overview
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Brief Summary
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This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-grazytracer in subjects with non-small cell lung cancer or melanoma receiving immune checkpoint inhibitors (e.g., Ipilimumab, Nivolumab). A single dose of 2.96 MBq/kg body weight of 68Ga-grazytracer will be injected intravenously. The visual and semiquantitative methods will be used to assess the PET/CT images.

Detailed Description
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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 cancer therapy in subjects with non-small cell lung cancer or melanoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects before and after receiving immune checkpoint inhibitors.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: 68Ga-grazytracer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old; ECOG score 0 or 1 point; Participants with confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging. Exclusion Criteria: Pregnant or nursing; Severe hepatic or renal dysfunction; Low WBC (less than 3 x 10^9/L); Unable to comply with the PET/CT imaging procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 68Ga-grazytracer PET/CT in participants before immunotherapy<br>Participants who have not undergone immunotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-grazytracer in one dose intravenously and then undergo PET/CT scan within 1 h. | Drug: 68Ga-grazytracer<br>* 68Ga-grazytracer PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.<br>|
| 68Ga-grazytracer PET/CT in participants after immunotherapy<br>Participants post-immunotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-grazytracer in one dose intravenously and then undergo PET/CT scan within 1 h. | Drug: 68Ga-grazytracer<br>* 68Ga-grazytracer PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of lesions | Visual analysis of 68Ga-grazytracer PET images will be performed by consensus reading by at least 3 experienced nuclear medicine physician. | 1 year | 
| Semiquantitative assessment of lesions | The standardized uptake values (SUVs) of 68Ga-grazytracer in lesions will be measured by the same nuclear medicine physician for all the cases | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, Immunotherapy, Immune checkpoint inhibition, Granzyme B, 68Ga labeling