NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000026658

Registered date:24/03/2017

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedUnresectable or metastatic malignant melanoma,unresectable or metastatic non small cell lung cancer
Date of first enrollment2017/03/24
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Drug: 64Cu-DOTA-nivolumab Device: 64Cu-DOTA-nivolumab PET

Outcome(s)

Primary OutcomeSensitivity; 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 OutcomeFeasibility of 64Cu-DOTA-nivolumab PET imaging Positive predive predictive value and negative predictive value of 64Cu-DOTA-nivolumab PET imaging

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1. Age more than 20 years old 2. Histologically confirmed malignant melanoma or non-small cell lung cancer. 3. Formalin fixed, paraffin embedded (FFPE) tumor sample to evaluate PD-1 expression with immunohistochemistory. 4. At least 1 site of measurable disease 5. Eastern Cooperative Oncology Group performance status of 0-2. 6. Patient must have normal organ and bone marrow function: WBC >= 2,000/mm3 Platelet count >= 75,000/mm3 Hemoglobin concentration >= 8.0 g/dL Aspartate aminotransferase and alanine amino transferase <= 100 IU/L Total bilirubin <= 1.5 mg/dL Serum creatinine <=1.5 mg/dL 7. Getting informed concents and agreement.
Exclude criteria1. 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.

Related Information

Contact

public contact
Name Asuka Kawachi/ Akihiko Shimomura
Address 5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan Japan
Telephone 03-3542-2511
E-mail akawachi@ncc.go.jp
Affiliation National Cancer Center Hospital, Tokyo, Japan Breast and Medical Oncology
scientific contact
Name Kenji Tamura
Address 5-1-1, Chuo-ku, Tsukiji, Tokyo, Japan Japan
Telephone 03-3542-2511
E-mail ketamura@ncc.go.jp
Affiliation National Cancer Center Hospital, Tokyo, Japan Breast and Medical Oncology