Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism

NCT06773663 | Recruiting Phase 1

• 1 other identifier: K5164
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-Pentixafor PET imaging in patients with primary aldosteronism. And evaluates the potential of Al18F-NOTA-Pentixafor PET imaging in surgical strategy guidance.

Conditions

Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma

Outcome Measures

Primary Outcomes (3)

• Safety of Al18F-NOTA-Pentixafor

  Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.

  From radiotracer injection to 24 hours post-injection.

• Diagnostic accuracy of Al18F-NOTA-Pentixafor PET/CT for PA

  SUVmax and SUVmean of adrenal lesions, normal adrenal glands, and liver will be measured. The lesion-to-liver ratio (LLR) and lesion-to-normal adrenal ratio (LAR) will be calculated. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or adrenal vein sampling (AVS) findings will serve as the reference standard to determine the sensitivity and specificity .

  Through study completion, 1-1.5 years (from enrollment to to the final clinical or pathological diagnosis at 6-month follow-up after Al18F-NOTA-Pentixafor PET/CT )

• Surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT

  Primary Aldosteronism Surgical Outcome (PASO) Criteria : 1. Complete Clinical Success:Blood pressure is completely normalized without the need for antihypertensive medications. 2. Partial Clinical Success:Blood pressure improves, requiring fewer antihypertensive medications or easier control. 3. Absent Clinical Success:No significant improvement in blood pressure, and medication requirements remain unchanged. 4. Complete Biochemical Success: Postoperative aldosterone-to-renin ratio normalizes, indicating full correction of aldosterone overproduction. 5. Partial Biochemical Success: Aldosterone levels decrease but do not fully normalize. 6. Absent Biochemical Success: No significant improvement in biochemical markers, suggesting persistent aldosterone overproduction.

  Through study completion, 1-1.5 years (from enrollment to 6-month follow-up after surgery guided by Al18F-NOTA-Pentixafor PET/CT)

Secondary Outcomes (2)

• SUVmax of normal organs

  From study completion to 6 months after completion.

• Absorbed dose of target organs

  From study completion to 6 months after completion.

Study Arms (1)

Al18F-NOTA-Pentixafor PET/CT

EXPERIMENTAL

Evaluation of dosimetry, safety, diagnostic accuracy, and surgical guidance ability of Al18F-NOTA-Pentixafor PET/CT in patients with primary aldosteronism

Combination Product: Al18F-NOTA-Pentixafor PET/CT

Interventions

Al18F-NOTA-Pentixafor PET/CT COMBINATION_PRODUCT

Participants will receive an intravenous injection of Al18F-NOTA-Pentixafor, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. CT and PET imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.

Al18F-NOTA-Pentixafor PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with adrenal masses suspected to be aldosterone-producing adenomas based on routine imaging (e.g., CT scans), or clinically diagnosed primary aldosteronism patients requiring subtyping
• Signed written informed consent, with willingness and ability to comply with study procedures.
• Female participants must be surgically sterilized or postmenopausal for over a year; if not, reliable contraception is required.
• Male participants must use reliable contraception during the study and refrain from sperm donation.

You may not qualify if:

• Severe neurological disorders, or any significant diseases affecting the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, or immune systems, or other serious illnesses.
• Diagnosis of claustrophobia.
• History of drug abuse or alcohol dependence.
• Pregnant or breastfeeding women.
• Poor venous access that would preclude repeated venipuncture.
• Use of experimental drugs or devices within one month prior to the study, where the safety or efficacy has not been established.
• Any condition that the study investigators deem could pose potential harm or jeopardize participant safety.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Xinchun Yan, PhD

CONTACT

+86 18513489856; xcyanpumch@163.com

Li Huo, MD

CONTACT

huoli@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: December 30, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 26, 2025

Record last verified: 2024-10

Locations

CN (1)