Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Recruiting now · Phase 1/Phase 2
Conditions studied: Cushing s Syndrome
In brief
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.
Key facts
- Study ID
- NCT07350707
- Run by
- Peking Union Medical College Hospital
- People needed
- 160
- Starts
- 2023-06-12
- Expected to finish
- 2027-02-12
- Last updated by the study team
- 2026-01-20
Who can join
Age: 10 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical suspicion or confirmed diagnosis of Cushing's syndrome, based on clinical features (e.g., central obesity, moon face, muscle weakness) and/or abnormal cortisol-related biochemical tests.
- Able and willing to undergo PET/CT imaging with both 68Ga-Pentixafor and, when applicable, 68Ga-DOTATATE.
- Willing to provide informed consent for participation in the study.
You may not qualify if…
- Prior administration of therapeutic or investigational radiopharmaceuticals within 5 physical half-lives before study imaging.
- Pregnancy or breastfeeding.
- History of allergic reaction to gallium-based tracers or related compounds.
- Clinically unstable condition or severe organ dysfunction that, in the investigator's opinion, would interfere with PET/CT imaging or study participation.
- Inability to complete both 68Ga-Pentixafor and, when applicable, 68Ga-DOTATATE PET/CT imaging due to clinical or logistical reasons.
Where it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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