Actively Recruiting
Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary Hyperparathyroidism
Led by Joseph Sferra · Updated on 2024-09-19
37
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
J
Joseph Sferra
Lead Sponsor
U
University of Toledo Health Science Campus
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on patients diagnosed with primary hyperparathyroidism who have had a SPECT-CT scan that did not clearly locate the parathyroid adenoma within the past year. The study aims to find out if lowering calcium levels with calcitonin before repeating the scan can improve the ability of SPECT-CT to detect the parathyroid adenoma. This is a phase 4 interventional trial sponsored by Joseph Sferra. Participants will receive calcitonin injections at a dose of 200 IU twice daily for two days, followed by a single dose on the day of the second SPECT-CT imaging. This treatment is intended to lower calcium levels prior to the scan. All subjects will be in this treatment group, and the study focuses on evaluating the sensitivity of the SPECT-CT after calcitonin pre-treatment. During the study, participants will undergo a second SPECT-CT scan to assess changes in imaging sensitivity. Researchers will monitor the success of the imaging and surgical outcomes over six months following surgery. The primary outcome is the sensitivity of the SPECT-CT one year after treatment, with secondary outcomes including surgical approach and success rate. Participants will be followed for safety and treatment results throughout the study period ending in 2026.
CONDITIONS
Brief Title
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary hyperparathyroidism
- Non-localizing SPECT-CT performed within 365 days prior to consent
- Desire for surgical treatment of primary hyperparathyroidism
- No contraindications to 99mTC-Sestamibi
- No contraindications to calcitonin treatment
- Serum calcium level before non-localizing SPECT-CT is at least 10.5 mg/dL
- Consent to participate and undergo a second SPECT-CT for research purposes
You will not qualify if you...
- Previous neck surgery including parathyroid tissue removal unless further surgery is medically necessary due to end organ damage
- Contraindication to 99mTC-Sestamibi SPECT-CT such as allergic reaction during prior scan
- Allergy to calcitonin
- Hypocalcemia
- Vitamin D deficiency
- Previous radioactive iodine treatment
- New thyroid medication prescribed after initial scan
- Lithium use within one year of scans
- Secondary hyperparathyroidism
- Benign familial hypocalciuric hypercalcemia
- Known malignancy, especially multiple endocrine neoplasia
- New thiazide diuretic prescription after initial scan
- Current use of calcium channel blockers
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive calcitonin treatment to lower high calcium levels before undergoing a SPECT-CT imaging exam.
Daily visits or dosing for 3 days
Duration - 1 day
Participants undergo a second SPECT-CT scan to assess parathyroid gland activity following calcitonin treatment.
1 imaging visit (in-person)
Duration - Up to 6 months
Participants are monitored for surgical outcomes and success rate following treatment and imaging.
Follow-up visits as scheduled up to 6 months
Trial Site Locations
Total: 1 location
1
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
Research Team
L
Leah Stevenson, MS
D
Dawn Muskiewicz, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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