Flurpiridaz F-18 PET/CT to Find Parathyroid Adenomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study compares Flurpiridaz F-18 PET/CT to the standard SPECT/CT imaging for identifying parathyroid adenomas in adults with primary hyperparathyroidism. Participants will have prior SPECT/CT imaging and planned parathyroid surgery within six months, and will receive Flurpiridaz F-18 PET/CT to assess diagnostic performance. The trial focuses on imaging accuracy to guide surgical planning. Outcomes will inform whether the new PET/CT approach offers improved localization over current imaging. Safety and feasibility of the imaging modality will also be monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients, at least 18 years of age
2. History of primary hyperparathyroidism as clinically confirmed by serum laboratory values of elevated calcium levels (\>10.2 mg/dl) and abnormal or inappropriately normal parathyroid hormone concentrations (normal range: 15 to 65 pg/ml).
3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
4. Participants must have had prior SPECT/CT sestamibi parathyroid imaging within 6 months of this investigational study or planned SPECT/CT sestamibi parathyroid imaging scheduled prior to this investigational study.
5. Planned surgery within 6 months following this investigational study.

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of the PET/CT scan will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential ( as self-reported by menstrual history) before the injection of radiotracer.
2. Inability to tolerate imaging procedures, including but not limited to claustrophobia, inability to remain still during scanning, or any other condition that, in the judgment of the investigator or treating physician, would interfere with safe or adequate imaging.
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.

Where it's running

• Unversity of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Victor Babatunde, MD — University of Pennsylvania
• Study coordinator: Erin Schubert, BA
• Email: erin.schubert@pennmedicine.upenn.edu
• Phone: 215-573-6569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-channel near-infrared imaging with AI to locate parathyroid glands

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• Using artificial intelligence to improve parathyroid adenoma detection

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.