Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03935984

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location status: Recruiting

Location contact

Roberta Redfern, PhD

CONTACT

[email protected]

419-291-7517

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitonin

Drug

Treatment with calcitonin to lower high calcium levels prior to reimaging exam

Other names: Miacalcin

Primary outcomes

  1. Sensitivity of SPECT-CT

    Time frame: one year

    conversion rate from non-localizing to localizing exam

Secondary outcomes

  1. Surgical Approach

    Time frame: 6 months

    Rate of minimally-invasive surgery compared to four gland exploration

  2. Success Rate

    Time frame: 6 months from surgery

    Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism

Study contacts

Contact information is provided by the study sponsor or research team.

Dawn Muskiewicz, MS

CONTACT

[email protected]

419-291-7517

Leah Stevenson, MS

CONTACT

[email protected]

419-291-3491

Sponsors and collaborators

Lead sponsor

Joseph Sferra

Other

Collaborators

  • University of Toledo Health Science Campus

Registry information

Official study title

Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 2, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.