Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Recruiting
NCT Number: NCT07350707
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
10 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
68Ga-Pentixafor
DrugAll 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.
Primary outcomes
-
Diagnostic value
Time frame: From baseline PET/CT assessment to end of study (approximately 12 months)
Sensitivity and Specificity of 68Ga-Pentxiafor PET/CT for Cushing's Syndrome
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking Union Medical College Hospital
Other
Registry information
Official study title
CXCR4-Targeted PET Imaging for the Differential Diagnosis of ACTH-Dependent and ACTH-Independent Cushing's Syndrome: A Prospective Observational Study
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jan 20, 2026
- Registry last updated
- Jan 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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