Recruiting

Calcitonin

Sponsor:

Joseph Sferra

Code:

NCT03935984

Conditions

Primary Hyperparathyroidism

Hypercalcemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calcitonin

Study Details

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 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.

Conditions

Primary Hyperparathyroidism

Hypercalcemia

Study ID

NCT03935984

Start date

May 29, 2019

Status verified date

Sep, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

Calcitonin

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

Primary outcome measure

  • Sensitivity of SPECT-CT [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Leah Stevenson, MS

419-291-3491leah.stevenson@promedica.org

Dawn Muskiewicz, MS

419-291-7517dawn.muskiewicz@promedica.org

Locations

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Roberta Redfern, PhD

419-291-7517roberta.redfern@promedica.org

More Information

Sponsor

Joseph Sferra

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joseph Sferra on 2024-09-19.