Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Last updated: September 16, 2024
Sponsor: Joseph Sferra
Overall Status: Active - Recruiting

Phase

4

Condition

Hyperparathyroidism

Parathyroid Disorders

Parathyroid Disease

Treatment

Calcitonin

Clinical Study ID

NCT03935984
19-018
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of primary hyperparathyroidism

  • Non-localizing SPECT-CT performed within 365 days prior to consent to participate instudy

  • 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

Exclusion Criteria:

  • Previous surgery to the neck, including resection of parathyroid tissue, exceptwhere end organ damage is present and further surgical intervention is medicallynecessary

  • Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction oradverse 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 atthe time of index scan and second scan)

  • Currently taking calcium channel blockers

  • Pregnancy

Study Design

Total Participants: 37
Treatment Group(s): 1
Primary Treatment: Calcitonin
Phase: 4
Study Start date:
May 29, 2019
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.