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64Cu-DOTA-nivolumab PET imaging in patients with malignant melanoma or non-small cell lung cancer.

Not Applicable
Conditions
nresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancer
Registration Number
JPRN-UMIN000026658
Lead Sponsor
ational Cancer Center Hospital, Tokyo, Japan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1. Previous any drug allergies. 2. Uncontrolled any comorbidities (eg; cardiovascular disease, diabetes and psychiatric disease) 3. Active systemic infectious disease 4. Previous history of interstitial lung disease or pulmonary fibrosis disease. 5. Pregnant or lactating women. 6. Patients who recognized inappropriate candidate by physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensitivity; proportion of 64Cu-DOTA-nivolumab PET positive patients within PD-1 positive tumors. Specificity; proportion of 64Cu-DOTA-nivolumab PET negative patients within PD-1 negative tumors.
Secondary Outcome Measures
NameTimeMethod
Feasibility of 64Cu-DOTA-nivolumab PET imaging Positive predive predictive value and negative predictive value of 64Cu-DOTA-nivolumab PET imaging
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