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

December 1, 2023 updated by: Alexander Vahrmeijer, Leiden University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2300RC
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander Vahrmeijer, MD, PhD
        • Sub-Investigator:
          • Martijn van Dam, MD
        • Sub-Investigator:
          • Sven Mieog, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients >18yo diagnosed with abdominal paragangliomas which underwent surgical resection

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Open surgical procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging
Time Frame: 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
perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging
Time Frame: 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
Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMO_GLL_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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