Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
United States37 participantsStarted 2019-05-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.