Status:

RECRUITING

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Lead Sponsor:

Joseph Sferra

Collaborating Sponsors:

University of Toledo Health Science Campus

Conditions:

Primary Hyperparathyroidism

Hypercalcemia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 leve...

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

Key Trial Info

Start Date :

May 29 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT03935984

Start Date

May 29 2019

End Date

December 31 2026

Last Update

September 19 2024

Active Locations (1)

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1

ProMedica Toledo Hospital

Toledo, Ohio, United States, 43606