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More info
You can access this
clinical trial
if you have
Primary Hyperparathyroidism
and you are
over 18
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Device: Fluobeam(TM) Imaging System (Fluoptics)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01598727. The sponsor of the trial is Sheffield Teaching Hospitals NHS Foundation Trust and it is looking for 10 volunteers for the current phase.
Official trial 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