NCT07350707

Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome

CXCR4-Targeted PET Imaging for the Differential Diagnosis of ACTH-Dependent and ACTH-Independent Cushing's Syndrome: A Prospective Observational Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In previous clinical practice, 68Ga-Pentixafor PET/CT has demonstrated promising diagnostic utility in various neuroendocrine tumors by targeting CXCR4, a chemokine receptor overexpressed in several ACTH-secreting neoplasms. Building on this, and leveraging the Nuclear Medicine expertise at Peking Union Medical College Hospital, we aim to conduct a prospective observational study investigating the role of CXCR4-targeted PET/CT imaging in patients with confirmed or suspected Cushing's syndrome. This study will focus on evaluating the capability of \^68Ga-Pentixafor PET/CT to assist in the differential diagnosis of ACTH-dependent and ACTH-independent subtypes, as well as in the localization of primary lesions in challenging cases. Imaging performance will be assessed in comparison with conventional modalities and/or 68Ga-DOTATATE PET/CT when available.

Conditions

• Cushing s Syndrome

Interventions

Type	Name	Description
DRUG	68Ga-Pentixafor	All enrolled participants will undergo \^68Ga-Pentixafor PET/CT to evaluate CXCR4 expression patterns and assist in the differential diagnosis of ACTH-dependent and ACTH-independent subtypes. In cases where ectopic ACTH syndrome (EAS) is clinically suspected-such as in patients with inconclusive pituitary imaging or discordant biochemical profiles-an additional \^68Ga-DOTATATE PET/CT scan will be performed as part of the diagnostic workup. This allows for a head-to-head comparison between CXCR4-targeted and somatostatin receptor (SSTR)-targeted imaging modalities in the localization of ACTH-secreting tumors.

Timeline

• Start date: 2023-06-12
• Primary completion: 2026-03-01
• Completion: 2027-02-12
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China