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Calcitonin Pre-treatment for Primary Hyperparathyroidism

This study is looking at whether giving calcitonin (a medicine to lower high calcium levels) before a SPECT-CT scan can help doctors better find parathyroid adenomas (growths on the parathyroid glands). You might be able to join if you have primary hyperparathyroidism (a condition where your parathyroid glands make too much parathyroid hormone, leading to high calcium levels) and a recent SPECT-CT scan that didn't clearly show the problem area. You also need to want surgery for your condition and not have any reasons you can't take calcitonin or 99mTC-Sestamibi (a substance used in the scan). The main goal is to see if this approach improves how well the SPECT-CT scan works, with results measured after one year. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to include 37 participants. It is not specified if it is randomized, blinded, or its phase.
What's involved
You will receive calcitonin treatment to lower your calcium levels right before having a re-imaging exam.
Compensation
Not stated in the trial record.
Follow-up
The sensitivity of the SPECT-CT will be measured at one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03935984

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
Joseph Sferra
~37 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Calcitonin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of SPECT-CT
Measured over one year

Conditions

Primary Hyperparathyroidism
Hypercalcemia

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HypercalcemiaPrimary Hyperparathyroidism

NCT03935984

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ProMedica Toledo Hospital

    Toledo, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joseph Sferra, MD · PRINCIPAL_INVESTIGATOR · University of Toledo College of Medicine

Who to contact

Leah Stevenson, MS
[email protected]
419-291-3491
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Sensitivity of SPECT-CTone year

    conversion rate from non-localizing to localizing exam