Usefulness of 68 Ga-Pentixafor PET/CT on Diagnosis and Management of Cushing Syndrome.
Jie Ding, Anli Tong, Marcus Hacker...
https://pubmed.ncbi.nlm.nih.gov/35452014Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06833437
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion A Randomized Cross-over Trial
Led by Qifu Li · Updated on 2026-02-05
178
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
Q
Qifu Li
Lead Sponsor
T
The Affiliated Hospital Of Southwest Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS), in identifying the subtype of primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) in patients with adrenal nodules. This prospective, multicenter, randomized crossover trial aims to compare the diagnostic performance of these methods based on biochemical and clinical remission outcomes, focusing on whether 68Ga-Pentixafor PET/CT is not less accurate than AVS. The main goal is to guide treatment decisions effectively based on these diagnostic results. Participants are randomly assigned to one of two groups: one group undergoes 68Ga-Pentixafor PET/CT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PET/CT. Treatment strategies are then guided by the diagnostic findings. Both interventions are diagnostic tests used to determine unilateral primary aldosteronism, with specific criteria for diagnosis based on imaging and sampling results. This crossover design allows each patient to receive both diagnostic methods in different orders. During the study, participants will be monitored with a primary focus on the proportion of complete biochemical remission at 6 months postoperatively. Additional assessments include clinical remission rates and diagnostic accuracy in the surgical population. The study includes follow-up visits at 6 months after treatment to evaluate outcomes. Safety and treatment effectiveness are monitored throughout the trial, which is expected to last until the end of 2029.
CONDITIONS
Brief Title
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Diagnosed with primary aldosteronism concurrent with autonomous cortisol secretion
- Have hypertension and are aged between 18 and 70 years
- Have adrenal adenoma confirmed by CT or MRI scan
You will not qualify if you...
- Unable to complete 68Ga-Pentixafor PET/CT or adrenal venous sampling (AVS)
- Refuse surgery or have contraindications for surgery
- Meet bypass AVS criteria: younger than 35 years, spontaneous low potassium, adrenal CT showing unilateral low-density adenoma (≥1cm), plasma aldosterone >300pg/ml
- Suspected familial hyperaldosteronism or Liddle syndrome
- Suspected pheochromocytoma or adrenal carcinoma
- Have active malignant tumors
- Have had previous adrenal surgery
- Long-term use of glucocorticoids
- Pregnant or lactating women; have alcohol or drug abuse or mental disorders
- Have severe heart failure (NYHA III or IV), recent serious cardiovascular or cerebrovascular events, severe anemia, serious liver or kidney disease
- Have systemic inflammatory response syndrome
- Have uncontrolled diabetes (fasting blood glucose ≥13.3 mmol/L)
- Are obese (BMI ≥35 kg/m²) or underweight (BMI ≤18 kg/m²)
- Untreated aneurysm
- Have other health conditions interfering with treatment
- Suspected primary bilateral macronodular adrenal hyperplasia or primary pigmented nodular adrenal disease
- Poor compliance or other reasons deemed unsuitable by investigators
- Have adrenal insufficiency requiring hormone replacement therapy
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 2 weeks
Participants undergo two diagnostic tests in a randomized order to determine the subtype of their condition. These tests are 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS).
2 visits (in-person) for diagnostic tests
Treatment
Duration - 6 months
Based on diagnostic results, participants receive appropriate treatment for their condition.
Follow-up
Duration - 6 months
Participants are followed for 6 months after treatment to assess biochemical and clinical remission.
Follow-up visits at 6 months post-treatment
Trial Site Locations
Total: 1 location
1
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
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Research Team
Q
Qifu Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
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Renata Libianto, Grant M Russell, Michael Stowasser...
https://pubmed.ncbi.nlm.nih.gov/35218017Primary Aldosteronism in Patients in China With Recently Detected Hypertension.
Zhixin Xu, Jun Yang, Jinbo Hu...
https://pubmed.ncbi.nlm.nih.gov/32327102Cortisol Co-Secretion and Clinical Usefulness of ACTH Stimulation Test in Primary Aldosteronism: A Systematic Review and Biases in Epidemiological Studies.
Kosuke Inoue, Takumi Kitamoto, Yuya Tsurutani...
https://pubmed.ncbi.nlm.nih.gov/33796078Prevalence of Cortisol Cosecretion in Patients With Primary Aldosteronism: Role of Metanephrine in Adrenal Vein Sampling.
Fabrizio Buffolo, Jacopo Pieroni, Federico Ponzetto...
https://pubmed.ncbi.nlm.nih.gov/36974473Aldosterone- and cortisol-co-secreting adrenal tumors: the lost subtype of primary aldosteronism.
Martin Späth, Svetlana Korovkin, Christiane Antke...
https://pubmed.ncbi.nlm.nih.gov/21270113The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.
John W Funder, Robert M Carey, Franco Mantero...
https://pubmed.ncbi.nlm.nih.gov/26934393Japan Endocrine Society clinical practice guideline for the diagnosis and management of primary aldosteronism 2021.
Mitsuhide Naruse, Takuyuki Katabami, Hirotaka Shibata...
https://pubmed.ncbi.nlm.nih.gov/35418526The 2020 Italian Society of Arterial Hypertension (SIIA) practical guidelines for the management of primary aldosteronism.
Gian Paolo Rossi, Valeria Bisogni, Alessandra Violet Bacca...
https://pubmed.ncbi.nlm.nih.gov/33447758Despite limited specificity, computed tomography predicts lateralization and clinical outcome in primary aldosteronism.
G A Kline, V C Dias, B So...
https://pubmed.ncbi.nlm.nih.gov/25002246