Cushing s SyndromePhase 1/2NCT07350707
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
A Phase 1/2 study testing 68Ga-Pentixafor in people with Cushing s Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Cushing s Syndrome
- What is being tested?
- 68Ga-Pentixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 12 Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, 86-13611093752, 13611093752@163.com
About this study
Official title: CXCR4-Targeted PET Imaging for the Differential Diagnosis of ACTH-Dependent and ACTH-Independent Cushing's Syndrome: A Prospective Observational Study
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
- Being tested
- 68Ga-Pentixafor
- Keywords
- pentixafor, CXCR4, PET/CT, Cushing s Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PentixaforDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-Pentixafor PET/CT | Experimental | 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. Receives: Drug: 68Ga-Pentixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-Pentxiafor PET/CT for Cushing's Syndrome
Measured: From baseline PET/CT assessment to end of study (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 Dec 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing s SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350707
- Sponsor's protocol ID
- PUMCH-68Ga-CXCR4-Cushing
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCR4-Targeted PET Imaging for the Differential Diagnosis of ACTH-Dependent and ACTH-Independent Cushing's Syndrome: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07350707
- Acronym / sponsor ID
- PUMCH-68Ga-CXCR4-Cushing
- Conditions
- Cushing s Syndrome
- Keywords
- pentixafor, CXCR4, PET/CT, Cushing s Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-Pentixafor PET/CT | Experimental | Drug: 68Ga-PentixaforAll 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. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-PentixaforAll 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. | Drug | 68Ga-Pentixafor PET/CT |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Cushing s Syndrome
Not yet recruitingObservational study
Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes
Cushing s Syndrome, Glucocorticoid Effect
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 2
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Hyperaldosteronism, Hypercortisolism
RecruitingPhase 2
Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
Cushing Syndrome
Enrolling by invitationObservational study
Comparative Study of Perioperative Cardiac Injury in Patients With Functional Adrenal Tumors
Primary Aldosteronism, Adrenal Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-Pentixafor in people with Cushing s Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Zhu, MD (86-13611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: From baseline PET/CT assessment to end of study (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.