What this study is
Simplified from ClinicalTrials.govTesting a scan using a radioactive tracer (Flurpiridaz F-18 PET/CT) to find overactive parathyroid glands, small neck glands that control calcium, in adults 18 and older with primary hyperparathyroidism who have known or suspected parathyroid adenomas and are going to have surgery to explore several parathyroid glands. The study compares it with the standard sestamibi SPECT/CT scan.
Read the original summary from ClinicalTrials.gov
Study of Flurpiridaz F-18 PET/CT as a diagnostic imaging tool to detect abnormal parathyroid glands in patients with primary hyperparathyroidism, prior to multi-parathyroid gland surgical exploration. Patients with known or suspected parathyroid adenomas will be eligible for this study. Comparisons of diagnostic performance using Flurpiridaz F-18 PET/CT versus standard of care dual time point sestamibi SPECT/CT imaging will be tested.
What's being tested
- Flurpiridaz PET/CT
Intervention · DRUG
Flurpiridaz is a FDA approved radiopharmaceutical used with PET/CT imaging
Study details
- Official title
- Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas in Patients With Primary Hyperparathyroidism
- Sponsor
- University of Pennsylvania
- Conditions
- Hyperparathyroidism
- Enrolling
- 20 people
- Starts
- 2026-08-15
- Est. completion
- 2029-09-01
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult patients, at least 18 years of age
- 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).
- 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.
- 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.
- Planned surgery within 6 months following this investigational study.
You can't join if
- 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.
- 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.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUnversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Erin Schubert, BA · Contact215-573-6569erin.schubert@pennmedicine.upenn.edu
- Mary Hansbury, BS · Contact215-746-8192mary.hansbury@pennmedicine.upenn.edu
- Victor Babatunde, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID 859544
Principal investigator
Victor Babatunde, MD
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.