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Trial Title:
PD-L2 Targeting Nanobody Radiotracer for PET Imaging of Solid Tumor
NCT ID:
NCT05803746
Condition:
Lung Cancer
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
All study participants will undergo one 18F-FDG PET/ CT scan.
Arm group label:
Imaging cohort
Summary:
The objective of this study is to construct a noninvasive approach using 68Ga- Mirc415
PET/CT to detect the PD-L2 expression of tumor lesion in patients with colorectal cancer,
lung cancer and other solid tumor to identify patients benefiting from anti-PD-(L)1
treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18-75, male and female, with ECOG score of 0 or 1;
2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer,
ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic
cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor
subjects who intend to undergo pathological tissue biopsy or receive tumor surgical
treatment in the near future (within 2 months);
3. The expected survival was more than 26 weeks;
4. Blood routine test, liver and kidney function meet the following standards: blood
routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L,
Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney
function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <=
2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP
<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists,
ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
5. According to RECIST1.1, there was at least one measurable target lesion;
6. Women must take effective contraceptive measures during the study period and within
6 months after the end of the study; men should agree to use contraceptive measures
during the study period and within 6 months after the end of the study period;
7. Understand and sign informed consent voluntarily with good compliance.
Exclusion Criteria:
1. The function of liver and kidney was seriously abnormal;
2. Preparation for pregnant, pregnant and lactating women;
3. Inability to lie flat for half an hour;
4. Suffering from claustrophobia or other mental disorders; 5) Other researchers
considered it unsuitable to participate in the trial. -
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhu
Phone:
010-88196495
Email:
zhuhuabch@pku.edu.cn
Start date:
July 15, 2022
Completion date:
July 15, 2024
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05803746