Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJoseph Sferra
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Calcitonin
DrugTreatment with calcitonin to lower high calcium levels prior to reimaging exam
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of SPECT-CT
conversion rate from non-localizing to localizing exam
Time frame
one yearSecondary outcomes
1
Surgical Approach
Rate of minimally-invasive surgery compared to four gland exploration
Time frame
6 months2
Success Rate
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
Time frame
6 months from surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Joseph Sferra
Lead sponsor
ProMedica Health System
Sponsor institution
University of Toledo Health Science Campus
Collaborator
Source ClinicalTrials.gov