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Trial · Interventional

RecruitingPhase 4Registry data

Calcitonin 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
2020202220242026
  1. Ph 4

    Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

    NCT03935984

    29 May 2019 to est. 31 Dec 2026

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.

  1. Sensitivity of SPECT-CT

    Time frame · one year

    Registry description

    conversion rate from non-localizing to localizing exam

Secondary outcomes(2)
  1. Surgical Approach

    Time frame · 6 months

    Registry description

    Rate of minimally-invasive surgery compared to four gland exploration

  2. 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
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 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 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 * 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

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