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

Paraganglioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155734
• Other study ID #: nWMO_GLL_1
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: December 2023
• Source: Leiden University Medical Center
• Contact: Martijn van Dam, MD
• Phone: 0715298420
• Email: m.a.van_dam[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: February 20, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Open surgical procedures

Related Conditions & MeSH terms

• Paraganglioma

Intervention

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

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging	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	perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.
Secondary	Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging	The 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	Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery