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New treatment option for Primary Hyperparathyroidism
Official title Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
ClinicalTrials.gov ID: NCT03935984
What this study is testing
What is Calcitonin?
Calcitonin is an investigational medicine, being studied as a potential treatment for primary hyperparathyroidism.
Also referred to as Miacalcin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toledo, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toledo, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.