Investigation of the Clinical Utility of [68Ga]Ga-NeoB PET in the Diagnosis of Gastrointestinal Cancers

JRCT ID: jRCTs051240087

Registered date:12/07/2024

Basic Information

• Recruitment status: Recruiting
• 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
• 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

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
• 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
• Source(s) of Monetary Support: Advanced Accerelator Applications