NCT03935984 Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
| NCT ID | NCT03935984 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Joseph Sferra |
| Condition | Primary Hyperparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2019-05-29 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 37 participants in total. It began in 2019-05-29 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Joseph Sferra, MD
PRINCIPAL INVESTIGATOR
University of Toledo College of Medicine
Frequently Asked Questions
Who can join the NCT03935984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03935984 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03935984 currently recruiting?
Yes, NCT03935984 is actively recruiting participants. Contact the research team at leah.stevenson@promedica.org for enrollment information.
Where is the NCT03935984 trial being conducted?
This trial is being conducted at Toledo, United States.
Who is sponsoring the NCT03935984 clinical trial?
NCT03935984 is sponsored by Joseph Sferra. The principal investigator is Joseph Sferra, MD at University of Toledo College of Medicine. The trial plans to enroll 37 participants.