RecruitingPhase 1Phase 2NCT07350707

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


Sponsor

Peking Union Medical College Hospital

Enrollment

160 participants

Start Date

Jun 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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Interventions

DRUG68Ga-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.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT07350707


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