Skip to content

Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green

Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06155734
Enrollment
6
Registered
2023-12-04
Start date
2023-11-11
Completion date
2024-02-20
Last updated
2023-12-04

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

Conditions

Paraganglioma

Keywords

Fluorescence Guided Surgery

Brief summary

This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures.

Interventions

During minimally invasive surgery using intravenous administration of indocyanine green (ICG) near-infrared fluorescence imaging will be applied to identify and treat paragangliomas

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with abdominal paraganglioma and underwent minimally-invasive surgical resection

Exclusion criteria

* Open surgical procedures

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imagingperioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.The primary outcome of this retrospective study is the ability to visually detect the proportion (%) of suspected pre-operatively identified lesions (paraganglioma) in the abdomen during minimally invasive procedures using Near-Infrared-fluorescence ICG imaging

Secondary

MeasureTime frameDescription
Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imagingPostoperatively, at the moment the definitive pathology result is known, approximately five days after surgeryThe secondary outcome of this retrospective study is the accuracy, measured by sensitivity and specificity to identify abdominal paragangliomas using using Near-Infrared-fluorescence ICG imaging

Countries

Netherlands

Contacts

Primary ContactMartijn van Dam, MD
m.a.van_dam@lumc.nl0715298420
Backup ContactAlexander L. Vahrmeijer, MD, PhD
a.l.vahrmeijer@lumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026