Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Phase 4

• Conditions: Primary Hyperparathyroidism; Hypercalcemia
• Interventions: Drug: Calcitonin

• Registration Number: NCT03935984
• Lead Sponsor: ProMedica Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-05-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-29
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Calcitonin	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

Primary Outcome Measures

Name	Time	Method
Sensitivity of SPECT-CT	one year	conversion rate from non-localizing to localizing exam

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States