JRCT ID: jRCTs051240087
Registered date:12/07/2024
Investigation of the Clinical Utility of [68Ga]Ga-NeoB PET in the Diagnosis of Gastrointestinal Cancers
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | gastrointestinal malignancy (esophageal, gastric, or colorectal cancer) |
Date of first enrollment | 12/07/2024 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Perform [68Ga]Ga-NeoB PET/CT for patients with gastrointestinal malignancies for staging and recurrence diagnosis. Additional PET/MRI will be performed for patients with rectal cancer. |
Outcome(s)
Primary Outcome | Diagnostic accuracy (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of [68Ga]Ga-NeoB PET in staging and restaging of gastrointestinal malignancies |
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Secondary Outcome | 1. Relationship between lesion uptake values on [68Ga]Ga-NeoB PET images and the expression rate of following proteins (HER2, PD-L1, Claudin18.2, etc.) (considered clinically important to influence treatment choice in gastrointestinal malignancies) 2. Relationship between lesion uptake values on [68Ga]Ga-NeoB PET images and genomic information obtained by gene expression analysis (GRPR, etc.) and whole exome analysis 3. Relationship between lesion uptake values on [68Ga]Ga-NeoB PET images and blood levels |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 85age old |
Gender | Both |
Include criteria | 1)Patients diagnosed with gastrointestinal malignancy (esophageal, gastric, or colorectal cancer) on histopathological examination, or strongly suspected of having gastrointestinal malignancy clinically or radiologically, or with a history of gastrointestinal malignancy and its metastasis or recurrence is suspected. 2)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2. |
Exclude criteria | 1.Pregnant or nursing 2.Outstandingly difficult in communication. 3.Very poor physical condition. 4.Others who are deemed inappropriate as research subjects by the principal investigator, the investigator, or the subinvestigators |
Related Information
Primary Sponsor | Nakamoto Yuji |
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Secondary Sponsor | |
Source(s) of Monetary Support | Advanced Accerelator Applications |
Secondary ID(s) |
Contact
Public contact | |
Name | Ryusuke Nakamoto |
Address | 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto Kyoto Japan 606-8507 |
Telephone | +81-75-751-3760 |
inabook@kuhp.kyoto-u.ac.jp | |
Affiliation | Kyoto University Hospital |
Scientific contact | |
Name | Yuji Nakamoto |
Address | 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto Kyoto Japan 606-8507 |
Telephone | +81-75-751-3760 |
ynakamo1@kuhp.kyoto-u.ac.jp | |
Affiliation | Kyoto University Hospital |