Using calcitonin to enhance SPECT-CT imaging for parathyroid adenoma localization
Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism
This study is testing if giving calcitonin to patients with primary hyperparathyroidism before a second SPECT-CT scan can help doctors find parathyroid adenomas that were missed in the first scan.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ProMedica Health System Academic / other |
| Locations | 1 site (Toledo, Ohio) |
| Trial ID | NCT03935984 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves patients diagnosed with primary hyperparathyroidism who have had a non-localizing SPECT-CT exam within the past year. Participants will receive calcitonin treatment to lower their calcium levels immediately before undergoing a second SPECT-CT imaging. The primary aim is to assess whether this pre-treatment improves the sensitivity of the imaging technique in localizing parathyroid adenomas. The study focuses on enhancing diagnostic accuracy to facilitate surgical intervention for patients seeking treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with biochemically confirmed primary hyperparathyroidism who have previously undergone a non-localizing SPECT-CT and are seeking surgical treatment.
Not a fit: Patients who have had prior neck surgery or have contraindications to calcitonin or SPECT-CT imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of imaging for parathyroid adenomas, leading to better surgical outcomes for patients.
How similar studies have performed: While the specific approach of using calcitonin for this purpose may be novel, similar studies have explored enhancing imaging techniques for parathyroid localization with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toledo, Ohio
- ProMedica Toledo Hospital — Toledo, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Sferra, MD — University of Toledo College of Medicine
- Study coordinator: Leah Stevenson, MS
- Email: leah.stevenson@promedica.org
- Phone: 419-291-3491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.