Recruiting
Early Phase 1

Flurpiridaz F-18 vs. Sestamibi

Sponsor:

University of Pennsylvania

Code:

NCT07910097

Conditions

Hyperparathyroidism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Flurpiridaz PET/CT

Study Details

Brief summary:

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.

Conditions

Hyperparathyroidism

Study ID

NCT07910097

Start date

Aug 15, 2026

Status verified date

Oct, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Flycardo PET/CT

Flycardo PET/CT scan in patients with primary hyperparathyroidism

Interventions

Flurpiridaz PET/CT

Flurpiridaz is a FDA approved radiopharmaceutical used with PET/CT imaging

Primary outcome measure

  • Sensitivity [ Time Frame: 4 weeks ]
  • sensitivity [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

Unversity of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Victor Babatunde, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • PET/CT
  • Flycardo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.