Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935984
• Other study ID #: 19-018
• Status: Recruiting
• Phase: Phase 4
• Start date: May 29, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2019
• Source: ProMedica Health System
• Contact: Roberta Redfern, PhD
• Phone: 419-291-7517
• Email: roberta.redfern[@]promedica.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: October 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Drug:
• Calcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam

Locations

Country	Name	City	State
United States	ProMedica Toledo Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
ProMedica Health System	University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of SPECT-CT	conversion rate from non-localizing to localizing exam	one year
Secondary	Surgical Approach	Rate of minimally-invasive surgery compared to four gland exploration	6 months
Secondary	Success Rate	Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism	6 months from surgery