Trial · Interventional
RecruitingPhase 4Registry dataCalcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 37 participants (estimated)
- Sponsor
- Joseph Sferra · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 29 May 2019
- Primary completion
- 1 Jun 2026 (estimated)
- Completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2019
- Last update posted
- 19 Sept 2024
- Conditions
- Primary Hyperparathyroidism · Hypercalcemia
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CalcitoninDrug
Arms1
Experimental
Treatment Group
All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging
Primary outcomes1
Outcomes the sponsor listed as primary.
Sensitivity of SPECT-CT
Time frame · one year
Registry description
conversion rate from non-localizing to localizing exam
Secondary outcomes(2)
Surgical Approach
Time frame · 6 months
Registry description
Rate of minimally-invasive surgery compared to four gland exploration
Success Rate
Time frame · 6 months from surgery
Registry description
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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