NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedgastrointestinal malignancy (esophageal, gastric, or colorectal cancer)
Date of first enrollment12/07/2024
Target sample size60
Countries of recruitment
Study typeInterventional
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 OutcomeDiagnostic accuracy (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of [68Ga]Ga-NeoB PET in staging and restaging of gastrointestinal malignancies
Secondary Outcome1. 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
Age maximum<= 85age old
GenderBoth
Include criteria1)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 criteria1.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

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
E-mail 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
E-mail ynakamo1@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Hospital