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

NCT06155734 | Unknown FDA Drug

• 1 other identifier: nWMO_GLL_1
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraganglioma

Keywords

Fluorescence Guided Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (1)

Retrospective intervention cohort

Drug: Fluorescence guided identification using indocyanine green

Interventions

Fluorescence guided identification using indocyanine green DRUG

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

Retrospective intervention cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Open surgical procedures

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2300RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Martijn van Dam, MD

CONTACT

0715298420; m.a.van_dam@lumc.nl

Alexander L. Vahrmeijer, MD, PhD

CONTACT

a.l.vahrmeijer@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, oncologic surgeon, MD, PhD

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 4, 2023
• Study Start: November 11, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 20, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

NL (1)