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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051240087

Enrollment

Registered

2024-07-12

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal malignancy (esophageal, gastric, or colorectal cancer) gastrointestinal malignancy, esophageal cancer, gastric cancer, colorectal cancer

Interventions

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.

E01.370.350.350.800.700.500

PET, PET/CT, PET/MRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of [68Ga]Ga-NeoB PET in staging and restaging of gastrointestinal malignancies	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactRyusuke Nakamoto

Kyoto University Hospital

inabook@kuhp.kyoto-u.ac.jp+81-75-751-3760

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026