No registrations found.
ID
Source
Brief title
Health condition
Parathyroid adenoma, Near-infrared fluorescence imaging, Methylene blue
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of methylene blue during operation.
Secondary outcome
Tumor-to-background signal of the identified adenomas.
Background summary
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.
Study objective
Delayed fluorescent near-infrared imaging can improve parathyroid adenoma identification using methylene blue.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
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.
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
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
Inclusion criteria
1. Patients diagnosed with primary hyperparathyroidism;
2. Age between 18 and 80.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4128 |
| NTR-old | NTR4279 |
| Other | METC Leiden : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |