Primary HyperparathyroidismPhase 4NCT03935984
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
A Phase 4 study testing Calcitonin in people with Primary Hyperparathyroidism and Hypercalcemia, run by Joseph Sferra at 1 site in United States.
Trial summary
Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Hypercalcemia
- What is being tested?
- Calcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 31 Dec 2026
- Phase
- Phase 4
- 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
- Diagnosis of primary hyperparathyroidism
- Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study
- Patient desires surgical intervention for treatment of PHPT
- No contraindications to 99mTC-Sestamibi
- No contraindications to treatment with calcitonin
- Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL
- Patient consents to participate and undergo second SPECT-CT for purposes of research
Who cannot join
- Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary
- Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT
- Allergy to calcitonin
- Hypocalcemia (contraindication to calcitonin)
- Vitamin D deficiency (contraindication to calcitonin)
- Previous treatment with radioactive iodine
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- New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan)
- Lithium exposure within one year of SPECT-CT (index and research scans)
- Secondary hyperparathyroidism
- Benign familial hypocalciuric hypercalcemia
- Known malignancy, particularly multiple endocrine neoplasia
- New prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan)
- Currently taking calcium channel blockers
- Pregnancy
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
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Roberta Redfern, PhD, 419-291-7517, roberta.redfern@promedica.org
About this study
Official title: Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism
Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia
- Being tested
- Calcitonin
- Medical subject headings
- Hyperparathyroidism, Primary, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitoninDrug
Also called Miacalcin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging Receives: Drug: Calcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of SPECT-CT
conversion rate from non-localizing to localizing exam
Measured: one year
Secondary outcomes (2)
Surgical Approach
Rate of minimally-invasive surgery compared to four gland exploration
Measured: 6 months
Success Rate
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
Measured: 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start29 May 2019
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Sferra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toledo Health Science Campus
- Responsible party
- Sponsor-investigator, Joseph Sferra, ProMedica Health System
- Investigators
- Joseph Sferra, MD, Principal investigator, University of Toledo College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935984
- Sponsor's protocol ID
- 19-018
- Status last verified
- Sep 2024
- First submitted
- 30 Apr 2019
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03935984
- Acronym / sponsor ID
- 19-018
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Joseph SferraUniversity, hospital or other
- Collaborators
- University of Toledo Health Science Campus
- Study start
- 29 May 2019 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2019 (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.
Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: CalcitoninAll subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of primary hyperparathyroidism
- Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study
- Patient desires surgical intervention for treatment of PHPT
- No contraindications to 99mTC-Sestamibi
- No contraindications to treatment with calcitonin
Key exclusion criteria (14 listed)
- Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary
- Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT
- Allergy to calcitonin
- Hypocalcemia (contraindication to calcitonin)
- Vitamin D deficiency (contraindication to calcitonin)
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 |
|---|---|---|
| CalcitoninAlso: MiacalcinTreatment with calcitonin to lower high calcium levels prior to reimaging exam | Drug | Treatment Group |
Primary outcome
Sensitivity of SPECT-CT
Time frame: one year
conversion rate from non-localizing to localizing exam
2 secondary outcomes
Surgical Approach
Time frame: 6 months
Success Rate
Time frame: 6 months from surgery
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Hyperparathyroidism
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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.
Joseph Sferra, MD principal investigator
University of Toledo College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitonin in people with Primary Hyperparathyroidism and Hypercalcemia, run by Joseph Sferra 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 7 inclusion and 14 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 19 Sep 2024. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Leah Stevenson, MS (419-291-3491, leah.stevenson@promedica.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of SPECT-CT (time frame: one year). 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 19 Sep 2024.