NCT07605156 Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion
| NCT ID | NCT07605156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2025-12-01 with a primary completion date of 2027-05-31.
⚠ 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
The goal of this observational study is to evaluate the diagnostic accuracy of 68 68 Ga-Pentixafor-CXCR4 PET/CT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for unilateral adrenalectomy or ablation. The main questions it aims to answer are: What is the overall diagnostic performance of 68 68 Ga-Pentixafor-CXCR4 PET/CT for lateralizing the dominant source of aldosterone and cortisol co-secretion, as measured by the area under the receiver operating characteristic curve (AUC)? How do the PET/CT-based lateralization results compare with adrenal venous sampling (AVS) and metanephrine-corrected AVS, and are there clinical or biochemical factors that predict discordance between these methods? Researchers will compare the dominant side determined by PET/CT with the reference standard derived from postoperative PASO outcomes and cortisol-related hormonal outcomes (supplemented by histopathology) to assess sensitivity, specificity, accuracy, and agreement. They will further compare PET/CT results to conventional AVS and metanephrine-corrected AVS to determine concordance and identify potential predictors of discordant cases. Participants will: Provide written informed consent and undergo baseline clinical, biochemical, and imaging assessments as part of routine PA+MACS work-up. Undergo a single 68 68 Ga-Pentixafor-CXCR4 PET/CT scan, along with AVS and metanephrine-corrected AVS, typically within a 4-week window. Be discussed by a multidisciplinary team that integrates all diagnostic information to formulate an individualized surgical plan. If surgery proceeds, be followed at 1, 3, 6, and 12 months postoperatively to assess blood pressure, antihypertensive medication use, serum potassium, aldosterone/renin/cortisol levels, and 1-mg overnight dexamethasone suppression test results.
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years. Confirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol \>1.8 µg/dL (\>50 nmol/L) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST). Scheduled to undergo \[⁶⁸Ga\]Pentixafor-CXCR4 PET/CT imaging. Meeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months. Exclusion Criteria: * Previous adrenal surgery or confirmed adrenal malignancy. Pregnancy or lactation. Severe renal impairment (eGFR \<30 mL·min-¹·1.73 m-²) or contraindication to contrast agents/radiopharmaceuticals. Inability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection/unstable comorbidities that preclude relevant examinations. Definite overt Cushing's syndrome (CS). Critical missing data, inability to complete the required examinations, or anticipated inability to attend follow-up.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07605156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07605156 currently recruiting?
Yes, NCT07605156 is actively recruiting participants. Contact the research team at 2300736651@qq.com for enrollment information.
Where is the NCT07605156 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07605156 clinical trial?
NCT07605156 is sponsored by Peking University First Hospital. The trial plans to enroll 130 participants.