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Search / Trial NCT03935984

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Launched by JOSEPH SFERRA · Apr 30, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called calcitonin can help improve the results of a special imaging test called SPECT-CT for patients with primary hyperparathyroidism, a condition that causes high levels of calcium in the blood. The study aims to see if lowering calcium levels with calcitonin before the imaging test will help doctors better locate the parathyroid adenoma, which is a growth that can cause these high calcium levels.

To participate in this trial, patients must have been diagnosed with primary hyperparathyroidism, have had a SPECT-CT scan within the last year that did not show clear results, and be looking for surgery to treat their condition. Eligible participants will receive calcitonin and then undergo a second SPECT-CT scan to see if the results improve. It's important to note that there are specific criteria for joining, including not having certain allergies or medical conditions. If you or a loved one are considering this trial, you can expect close monitoring and support throughout the process.

Gender

ALL

Eligibility criteria

  • 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

About Joseph Sferra

Joseph Sferra is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the pharmaceutical and biotechnology sectors, Sferra oversees the design, implementation, and management of clinical trials aimed at evaluating innovative therapies and treatments. His focus on rigorous scientific methodology and regulatory compliance ensures the integrity and reliability of trial data. Through strategic partnerships and a patient-centered approach, Joseph Sferra aims to contribute significantly to the development of new medical solutions that address unmet clinical needs.

Locations

Toledo, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Joseph Sferra, MD

Principal Investigator

University of Toledo College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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