Early phase 1: testing Flurpiridaz PET/CT for Hyperparathyroidism
Study of Flurpiridaz F-18 positron emission tomography/computed tomography (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.
Official registry: https://clinicaltrials.gov/study/NCT07910097 · University of Pennsylvania · enrollment listed as 20
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Flurpiridaz PET/CT. The registry lists allocation as na. Study of Flurpiridaz F-18 positron emission tomography/computed tomography (PET/CT) as a diagnostic imaging tool to detect abnormal parathyroid glands in patients with primary hyperparathyroidism, prior to multi-parathyroid gland surgical exploration.
They plan to enroll about 20 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas in Patients With Primary Hyperparathyroidism
Interventions: Flurpiridaz PET/CT
Primary outcome (registry wording): Sensitivity
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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 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
Who the registry excludes
- 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
Public study contact (from the registry)
Erin Schubert, BA
erin.schubert@pennmedicine.upenn.edu
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Unversity of Pennsylvania — Philadelphia, Pennsylvania (recruiting)
FAQ about this NCT record
Is NCT07910097 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07910097?
Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07910097?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary