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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000372
Recruitment Status : Not yet recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
Peking University Health Science Center
Information provided by (Responsible Party):
Hua Zhu, Peking University Cancer Hospital & Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: 68Ga-grazytracer Early Phase 1

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects With Non-small Cell Lung Cancer or Melanoma
Estimated Study Start Date : August 15, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Visual assessment of lesions [ Time Frame: 1 year ]
    Visual analysis of 68Ga-grazytracer PET images will be performed by consensus reading by at least 3 experienced nuclear medicine physician.

  2. Semiquantitative assessment of lesions [ Time Frame: 1 year ]
    The standardized uptake values (SUVs) of 68Ga-grazytracer in lesions will be measured by the same nuclear medicine physician for all the cases


Other Outcome Measures:
  1. Granzyme B expression analysis of tumor tissues [ Time Frame: 1 year ]
    Tumor tissues obtained from biopsy or surgery will be stained for granzyme B

  2. Correlation analysis of 68Ga-grazytracer uptake and lesion size changes [ Time Frame: 1 year ]
    The SUVs of 68Ga-grazytracer in individual lesions will be compared to the changes in lesion sizes



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-75 years old;
  2. ECOG score 0 or 1 point;
  3. Participants with suspected or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000372


Contacts
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Contact: Haoyi Zhou +8610-82802893 2011110024@bjmu.edu.cn

Sponsors and Collaborators
Peking University Cancer Hospital & Institute
Peking University Health Science Center
Investigators
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Study Director: Nan Li, M.D. Peking University Cancer Hospital & Institute
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Responsible Party: Hua Zhu, Prof., Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT05000372    
Other Study ID Numbers: 2021KT86
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hua Zhu, Peking University Cancer Hospital & Institute:
PET/CT
Immunotherapy
Immune checkpoint inhibition
Granzyme B
68Ga labeling
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas