NCT07350707 Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
| NCT ID | NCT07350707 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Cushing s Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2025-12-25 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07350707 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 80 Years, studying Cushing s Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07350707 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07350707 currently recruiting?
Yes, NCT07350707 is actively recruiting participants. Contact the research team at 13611093752@163.com for enrollment information.
Where is the NCT07350707 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07350707 clinical trial?
NCT07350707 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 160 participants.