NCT07254104

Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the clinical application value of \[68Ga\]Ga-NOTA-RF, a novel PET molecular probe targeting riboflavin transporter 3 (RFVT3), in patients with pituitary adenomas. It will observe the probe's imaging characteristics, distribution signs, and the relationships between these factors, tumor differentiation degree, and radiotracer uptake. Additionally, the study will explore the diagnostic advantages of \[68Ga\]Ga-NOTA-RF in patients with pituitary adenomas and its potential value in precise typing.

Detailed description

This study aims to evaluate the potential clinical application of \[68Ga\]Ga-NOTA-RF in pituitary adenomas. Such tumors are characterized by variable degrees of differentiation, subtle early morphological changes, complex metabolic states, and a strong dependence on mitochondrial activity. Existing imaging modalities have limited performance in detecting and characterizing these lesions, highlighting the need for novel metabolic imaging tools. This study will systematically investigate the biodistribution and imaging characteristics of \[68Ga\]Ga-NOTA-RF in pituitary adenomas, as well as its correlation with RFVT3 expression, to explore its potential value in early tumor detection, metabolic subtype differentiation, and molecular classification.

Conditions

• Pituitary Neoplasms

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-NOTA-RF	Administer the \[68Ga\]Ga-NOTA-RF radiotracer via injection.

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-10-13
• Completion: 2026-10-13
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: China