HyperparathyroidismEarly Phase 1NCT07910097
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
A Early Phase 1 study testing Flurpiridaz PET/CT in people with Hyperparathyroidism, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- Flurpiridaz PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 1 Sep 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Unversity of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Schubert, BA, 215-573-6569, erin.schubert@pennmedicine.upenn.edu
Mary Hansbury, BS, 215-746-8192, mary.hansbury@pennmedicine.upenn.edu
About this study
Official title: Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas in Patients With Primary Hyperparathyroidism
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.
Read the detailed description
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
- Being tested
- Flurpiridaz PET/CT
- Keywords
- PET/CT, Flycardo
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurpiridaz PET/CTDrug
Flurpiridaz is a FDA approved radiopharmaceutical used with PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Flycardo PET/CT | Experimental | Flycardo PET/CT scan in patients with primary hyperparathyroidism Receives: Drug: Flurpiridaz PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Qualitative positive or negative PET/CT
Measured: 4 weeks
sensitivity
comparison of specificity of PET/CT imaging with standard dual-energy Sestamibi imaging
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Aug 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Babatunde, University of Pennsylvania
- Investigators
- Victor Babatunde, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910097
- Sponsor's protocol ID
- 859544
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas in Patients With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT07910097
- Acronym / sponsor ID
- 859544
- Conditions
- Hyperparathyroidism
- Keywords
- PET/CT, Flycardo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flycardo PET/CT | Experimental | Drug: Flurpiridaz PET/CTFlycardo PET/CT scan in patients with primary hyperparathyroidism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flurpiridaz PET/CTFlurpiridaz is a FDA approved radiopharmaceutical used with PET/CT imaging | Drug | Flycardo PET/CT |
Primary outcome
Sensitivity
Time frame: 4 weeks
Qualitative positive or negative PET/CT
sensitivity
Time frame: 6 weeks
comparison of specificity of PET/CT imaging with standard dual-energy Sestamibi imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Babatunde, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Flurpiridaz PET/CT in people with Hyperparathyroidism, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Schubert, BA (215-573-6569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.