ClinicalTrials.gg
RecruitingNCT03935984Updated Sep 19, 2024

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

A Phase 4 interventional study of Calcitonin in Primary Hyperparathyroidism and Hypercalcemia, sponsored by Joseph Sferra. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Joseph Sferra · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2019; still recruiting 7 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hyperparathyroidism
  • Hypercalcemia
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's planned enrollment of 37 is below the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

This is the only study on the registry with Joseph Sferra as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
  • 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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • 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

    Drug: Calcitonin

Interventions

  • Treatment with calcitonin to lower high calcium levels prior to reimaging exam

    Also known as: Miacalcin

06

What researchers measure

Primary outcomes

  1. Sensitivity of SPECT-CT

    conversion rate from non-localizing to localizing exam

    Time frame: one year

Secondary outcomes

  1. Surgical Approach

    Rate of minimally-invasive surgery compared to four gland exploration

    Time frame: 6 months

  2. Success Rate

    Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism

    Time frame: 6 months from surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03935984
Lead sponsor
Joseph Sferra
Collaborators
University of Toledo Health Science Campus
Responsible party
Joseph Sferra (Chief of Surgery, ProMedica Health System) — Sponsor-investigator
First posted
May 2, 2019
Start date
May 29, 2019
Primary completion
Jun 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Leah Stevenson, MS
Contact
leah.stevenson@promedica.org
419-291-3491
Dawn Muskiewicz, MS
Contact
dawn.muskiewicz@promedica.org
419-291-7517
Joseph Sferra, MD
principal investigator · University of Toledo College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Calcitonin

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