Status:
TERMINATED
Image-guided Lymphadanectomy in AMIGO
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Siemens Corporation, Corporate Technology
KARL STORZ Endoscopy-America, Inc.
Conditions:
Lymphadenopathy Retroperitoneal
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of minimizing surgical risk and improving accuracy of biopsy.
Detailed Description
Only the superficial lymph nodes are accessible to physical examination, and assessment of deeper nodes, such as those in the abdomen, requires radiological imaging. As a result, abdominal CT and PET ...
Eligibility Criteria
Inclusion
- Signed written informed consent before any trial related procedure is undertaken that is not part of the standard patient management
- Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in the abdomen or retroperitoneum, with scheduled confirmatory surgical biopsy.
- Subjects must have had a CT, PET examination or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month
Exclusion
- Severely impaired renal function with an EGFR \< 30 mL/min/body surface area
- Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
- History of hypersensitivity or other contraindication to contrast media
- Contraindication to general anesthesia
- Pregnancy
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03283423
Start Date
October 25 2018
End Date
March 20 2020
Last Update
January 9 2026
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115