Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Hyperparathyroidism; Hypercalcemia
• Intervention / Treatment: Drug: Calcitonin

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Roberta Redfern, PhD; Phone Number: 419-291-7517; Email: roberta.redfern@promedica.org
• Study Contact Backup: Name: Sara Seegert, MSN; Phone Number: 419-291-7709; Email: sara.seegert@promedica.org

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Contact: Roberta Redfern, PhD; Phone Number: 419-291-7517; Email: roberta.redfern@promedica.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Calcitonin; Treatment with calcitonin to lower high calcium levels prior to reimaging exam; Other Names: Miacalcin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of SPECT-CT	conversion rate from non-localizing to localizing exam	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ProMedica Health System
• Collaborators: University of Toledo Health Science Campus
• Investigators: Principal Investigator: Juan Jaume, MD, University of Toledo College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Endocrine System Diseases; Parathyroid Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hyperparathyroidism; Hyperparathyroidism, Primary; Hypercalcemia; Physiological Effects of Drugs; Vasodilator Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
• Other Study ID Numbers: 19-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No