RECRUITING

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Conditions

Primary Hyperparathyroidism Hypercalcemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-05-29

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03935984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Leah Stevenson, MS

CONTACT

419-291-3491

leah.stevenson@promedica.org

Dawn Muskiewicz, MS

CONTACT

419-291-7517

dawn.muskiewicz@promedica.org

Principal Investigator

Joseph Sferra, MD

PRINCIPAL_INVESTIGATOR

University of Toledo College of Medicine

Study Locations (Sites)

ProMedica Toledo Hospital

Toledo, Ohio, 43606

United States

Collaborators and Investigators

Sponsor: Joseph Sferra

Joseph Sferra, MD, PRINCIPAL_INVESTIGATOR, University of Toledo College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-29

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-05-29

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Primary Hyperparathyroidism
Hypercalcemia