Delayed fluorescent near-infrared imaging can improve parathyroid adenoma identification using methylene blue.
ID
Bron
Verkorte titel
Aandoening
Parathyroid adenoma, Near-infrared fluorescence imaging, Methylene blue
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Intra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of methylene blue during operation.
Achtergrond van het onderzoek
One of the main challenges in parathyroid surgery for primary hyperparathyroidism is the intraoperative adenoma detection. Especially intra-operative detection of small adnomas has proven to be very difficult. Near-infrared fluorescent (NIRF) imaging is a recently developed method to visualize vital structures and tumors. Previous research has shown that intraopertaive visualization of parathyroid adenomas using methylene blue is feasibile. The aim of this study is to improve visualization bye comparing early and delayed imaging protocols after iv administration of Methylene Blue.
Doel van het onderzoek
Delayed fluorescent near-infrared imaging can improve parathyroid adenoma identification using methylene blue.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
Standard parathyroid adenoma resectino will be performed. Just before sugery of after opening the neck region, methylene blue will be injected intravenously to identify the parathyroid adenoma using NIR fluorenscence.
Publiek
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Wetenschappelijk
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients diagnosed with primary hyperparathyroidism;
2. Age between 18 and 80.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4128 |
| NTR-old | NTR4279 |
| Ander register | METC Leiden : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |