Using calcitonin to enhance SPECT-CT imaging for parathyroid adenoma localization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves patients diagnosed with primary hyperparathyroidism who have had a non-localizing SPECT-CT exam within the past year. Participants will receive calcitonin treatment to lower their calcium levels immediately before undergoing a second SPECT-CT imaging. The primary aim is to assess whether this pre-treatment improves the sensitivity of the imaging technique in localizing parathyroid adenomas. The study focuses on enhancing diagnostic accuracy to facilitate surgical intervention for patients seeking treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• ProMedica Toledo Hospital
  Toledo, Ohio, United States Recruiting

Study contacts

• Principal investigator: Joseph Sferra, MD — University of Toledo College of Medicine
• Study coordinator: Leah Stevenson, MS
• Email: leah.stevenson@promedica.org
• Phone: 419-291-3491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.