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Search / Trial NCT05891769

99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

Launched by ANDREI IAGARU · May 26, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two imaging techniques to help diagnose a condition called parathyroid adenoma, which can cause high levels of calcium in the blood. The trial specifically looks at a type of imaging called 18F Fluorocholine PET/CT to see how well it works compared to the traditional 99mTc Sestamibi SPECT/CT, especially in patients whose previous scans were inconclusive or negative. The study is currently recruiting participants aged 65 to 74 who have signs of parathyroid adenoma but did not get clear results from the standard imaging test.

To be eligible for the trial, individuals must have elevated calcium levels and abnormal parathyroid hormone levels, and they should be able to provide written consent. Participants will receive the new imaging test and may help researchers better understand its effectiveness. It's important to note that women who are pregnant cannot participate, and there are specific health criteria regarding liver and kidney function that must be met. Overall, this trial aims to improve the way doctors identify and diagnose parathyroid adenomas, which could lead to better treatment options for patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
  • 2. Negative or equivocal 99mTc Sestamibi SPECT/CT
  • 3. Able to provide written consent
  • 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
  • 6. Karnofsky performance status of \>50 (or ECOG/WHO equivalent)
  • 7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
  • Exclusion Criteria:
  • 1. Less than 18 years old at the time of radiotracer administration
  • 2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
  • 3. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome

About Andrei Iagaru

Andrei Iagaru is a distinguished clinical trial sponsor renowned for his commitment to advancing medical research and improving patient outcomes. With a robust background in nuclear medicine and oncology, Dr. Iagaru leads innovative clinical studies that focus on the development and evaluation of novel diagnostic and therapeutic approaches. His expertise in imaging and molecular medicine fosters collaboration among multidisciplinary teams, driving the translation of groundbreaking scientific discoveries into effective clinical applications. Through his leadership, the trials sponsored by Dr. Iagaru prioritize patient safety and adhere to the highest ethical standards, ultimately contributing to the advancement of healthcare solutions.

Locations

Stanford, California, United States

Patients applied

0 patients applied

Trial Officials

Andrei Iagaru, MD

Study Director

Stanford University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported