Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

NCT03935984 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 19-018
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of SPECT-CT

  conversion rate from non-localizing to localizing exam

  one year

Secondary Outcomes (2)

• Surgical Approach

  6 months

• Success Rate

  6 months from surgery

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

Calcitonin DRUG

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

Also known as: Miacalcin

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Sferra: lead
• University of Toledo Health Science Campus: collaborator

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Hypercalcemia

Interventions

Calcitonin; salmon calcitonin

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Joseph Sferra, MD

  University of Toledo College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Stevenson, MS

CONTACT

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

Dawn Muskiewicz, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Surgery

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: May 29, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)