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Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
Plain-language guide to NCT02089542: phase 1, phase 2 interventional trial of Methylene blue (non-peptide stack partner), hyperparathyroidism, 41 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02089542
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2014-10
- Completion (planned or actual)
- 2016-06
- Participants
- 41 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Total Thyroidectomy; Bilateral Neck Exploration for Primary Hyperparathyroidism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested Methylene blue (non-peptide stack partner) for hyperparathyroidism.
Reliable identification of parathyroid glands is critical to the success of thyroid and parathyroid surgery.
In thyroid surgery, inadvertent injury to parathyroid glands may cause temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment).
It had 1 arm (groups): MB and fluorescent imaging (experimental).
The registry classes the interventions as other.
More on the Plan
Around 13,000 thyroid and parathyroid operations are performed per year in England for both benign and malignant disease.
MB is not currently used in surgery for thyroid pathologies.
Who Took Part
Enrollment: 41 actual participants took part.
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.
The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: patients undergoing re-do procedures; patients unable to understand spoken and written english; patients unable to give adequate informed consent.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-10 with completion listed for 2016-06.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Time to peak fluorescence.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Methylene blue (non-peptide stack partner) in 41 people with hyperparathyroidism.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Methylene blue (non-peptide stack partner) compound page, Hyperparathyroidism research.
Our Notes on the Compound
Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.
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.