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

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06155734
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Paraganglioma	Drug: Fluorescence guided identification using indocyanine green

Study Design

• Study Type: Observational
• Anticipated Enrollment: 6 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green
• Actual Study Start Date: Nov 11, 2023
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Feb 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Retrospective intervention cohort	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

Outcome Measures

Primary Outcome Measures

1. Feasibility of real-time in-vivo identification of suspected paraganglioma's 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.]

   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 Outcome Measures

1. Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging [Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Open surgical procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center	Leiden		Netherlands	2300RC

Sponsors and Collaborators

• Leiden University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander Vahrmeijer, Principle investigator, oncologic surgeon, MD, PhD, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT06155734
• Other Study ID Numbers: nWMO_GLL_1
• First Posted: Dec 4, 2023
• Last Update Posted: Dec 4, 2023
• Last Verified: Dec 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alexander Vahrmeijer, Principle investigator, oncologic surgeon, MD, PhD, Leiden University Medical Center: Fluorescence Guided Surgery
• Additional relevant MeSH terms: Paraganglioma

Study Results

No Results Posted as of Dec 4, 2023