Primary Hyperparathyroidism Clinical Trial
Official title:
A Phase I Feasibility Study of Intra-operative Near Infra-red Fluorescent Imaging in Thyroid/Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection
of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid
surgery.
Aims: The aims of this phase of the study are to determine the feasibility of using near
infrared fluorescent technology in the detection of parathyroid tissue and its
differentiation from adjacent soft tissue during surgery on parathyroid glands.
Objectives of the phase I study:
1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device
(Fluoptics).
2. To understand the patterns (onset, intensity and duration) of fluorescent staining of
normal parathyroid glands, thyroid glands and other soft tissue structures encountered
during parathyroidectomy.
Further research:
This will be followed by a phase II study during which fluorescent imaging will be used in
conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and
parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum
possible dose of MB for the identification of parathyroid glands. This will then be tested
in the pilot phase of a randomized clinical trial.
As above ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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