DRUG
Calcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Status
Recruiting
Phase
Phase 4
Enrollment
37
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Timeline
First posted
May 2, 2019
Study start
May 29, 2019
Primary completion
Jun 1, 2026
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Sep 19, 2024
Outcomes
Sensitivity of SPECT-CT
Time frame · one year
conversion rate from non-localizing to localizing exam
Surgical Approach
Time frame · 6 months
Rate of minimally-invasive surgery compared to four gland exploration
Success Rate
Time frame · 6 months from surgery
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ProMedica Toledo Hospital
Toledo, Ohio, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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