Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Overview

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.

Full Title of Study: “Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2021

Interventions

  • Drug: Calcitonin
    • Treatment with calcitonin to lower high calcium levels prior to reimaging exam

Arms, Groups and Cohorts

  • Experimental: Treatment Group
    • All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity of SPECT-CT
    • Time Frame: one year
    • conversion rate from non-localizing to localizing exam

Secondary Measures

  • Surgical Approach
    • Time Frame: 6 months
    • Rate of minimally-invasive surgery compared to four gland exploration
  • Success Rate
    • Time Frame: 6 months from surgery
    • Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ProMedica Health System
  • Collaborator
    • University of Toledo Health Science Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Juan Jaume, Principal Investigator – ProMedica Health System
  • Overall Official(s)
    • Juan Jaume, MD, Principal Investigator, University of Toledo College of Medicine
  • Overall Contact(s)
    • Roberta Redfern, PhD, 419-291-7517, roberta.redfern@promedica.org

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