Current partner codePEPTIDESDE
NCT03935984·Phase 4·INTERVENTIONAL

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Status

Recruiting

Phase

Phase 4

Enrollment

37

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Calcitonin

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

Timeline

From registration to results.

  1. First posted

    May 2, 2019

  2. Study start

    May 29, 2019

  3. Primary completion

    Jun 1, 2026

  4. Study completion

    Dec 31, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2024

Outcomes

What the study measures.

Primary outcomes

Sensitivity of SPECT-CT

Time frame · one year

conversion rate from non-localizing to localizing exam

Secondary outcomes

Surgical Approach

Time frame · 6 months

Rate of minimally-invasive surgery compared to four gland exploration

Success Rate

Time frame · 6 months from surgery

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ProMedica Toledo Hospital

Toledo, Ohio, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.