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Intra-operatieve fluorescente beeldvorming van bijschildklieren.

Intraoperative Near-Infrared Fluorescence Imaging of Parathyroid Adenomas using Low-Dose Methylene Blue.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21918
Enrollment
15
Registered
2012-04-19
Start date
2012-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid adenoma, near-infrared fluorescence imaging, methylene blue

Interventions

Standard parathyroid adenoma resectino will be performed. After opening the neck region, methylene blue will be injected intravenously to identify the parathyroid adenoma using NIR fluorenscence.

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with primary hyperparathyroidism; 2. Age between 18 and 80.

Exclusion criteria

Exclusion criteria: 1. Allergy for Methylene blue; 2. Patients using SSRIs, SNRIs of TCAs; 3. Pregnancy; 4. Severe renal impairment; 5. Patients with a G6PD deficiency.

Design outcomes

Primary

MeasureTime frame
Intra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of methylene blue during operation.

Secondary

MeasureTime frame
Tumor-to-background signal of the identified adenomas.

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)