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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 18-75 years old; 2. ECOG score 0 or 1 point; 3. 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:

1. Pregnant or nursing; 2. Severe hepatic or renal dysfunction; 3. Low WBC (less than 3 x 10^9/L); 4. Unable to comply with the PET/CT imaging procedures.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05000372
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Cancer Hospital & Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nan Li, M.D.
Principal Investigator Affiliation	Peking University Cancer Hospital & Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer

Additional Details

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.

Arms & Interventions

Arms

: 68Ga-grazytracer PET/CT in participants before immunotherapy

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.

: 68Ga-grazytracer PET/CT in participants after immunotherapy

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.

Interventions

Drug: - 68Ga-grazytracer

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.

Contact a Trial Team

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