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Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Plain-language guide to NCT03935984: phase 4 interventional trial of Calcitonin, hyperparathyroidism, 37 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03935984
Phase
phase 4
Status
recruiting participants
Start
2019-05-29
Completion (planned or actual)
2026-06-01
Participants
37 (estimated)
Design
na, open label (everyone knows who gets what), diagnostic
Conditions studied
Primary Hyperparathyroidism; Hypercalcemia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Calcitonin for hyperparathyroidism.

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.

It had 1 arm (groups): Treatment Group (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 37 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Calcitonin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-05-29 with completion listed for 2026-06-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Sensitivity of SPECT-CT (time frame: one year).

It also tracked 2 secondary outcomes, for example Surgical Approach and Success Rate.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Calcitonin in 37 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, Hyperparathyroidism research.

Our Notes on the Compound

Calcitonin: A 32-amino-acid hormone that lowers blood calcium; salmon calcitonin (Miacalcin) has been used for Paget disease and osteoporosis.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.