- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803315
Hyperspectral Imaging in Robot-Assisted Partial Nephrectomy (HSI-Renal)
Perfusion Mapping and Tissue Characterization Using Hyperspectral Imaging in Robot-Assisted Partial Nephrectomy
The goal of this prospective observational study is to learn about the use of a novel imaging technique called hyperspectral imaging in adult participants who are having surgery for removing a tumor from their kidney. Hyperspectral imaging works by shining light on a structure (in this case, the kidney tissue with the tumor) and capturing how it reflects hundreds of very narrow color bands, including ones the human eye can't see. These patterns depend on the composition of the tissue and for example how well blood is flowing through the tissue. By studying these patterns, the investigators want to understand if this technique can be helpful for the surgery where only the part of the kidney with the tumor is removed.
The main questions it aims to answer are:
- Can hyperspectral imaging show the areas of blood flow in the kidney during surgery?
- Is there a connection between the detected patterns of light and the type of kidney tumor?
The imaging will happen during the already planned surgery and the participant does not need to undergo any additional tests.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jens-Uwe Stolzenburg, Professor Dr.
- Phone Number: +49 3419717600
- Email: jens-uwe.stolzenburg@medizin.uni-leipzig.de
Study Contact Backup
- Name: Doreen Trebst, Dr.
- Phone Number: +49 3419717610
- Email: doreen.trebst@medizin.uni-leipzig.de
Study Locations
-
-
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Leipzig, Germany, 04103
- Recruiting
- University Hospital Leipzig
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Contact:
- Jens-Uwe Stolzenburg, Professor Dr.
- Phone Number: +49 3419717600
- Email: jens-uwe.stolzenburg@medizin.uni-leipzig.de
-
Contact:
- Doreen Trebst, Dr.
- Phone Number: +49 3419717610
- Email: doreen.trebst@medizin.uni-leipzig.de
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Principal Investigator:
- Jens-Uwe Stolzenburg, Prof. Dr.
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Principal Investigator:
- Doreen Trebst, Dr.
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Sub-Investigator:
- Sigrun Holze, Dr.
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Sub-Investigator:
- Clara Steiner, Dr.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with a kidney tumor ≤7cm
- planned robot-assisted partial nephrectomy
- age ≥ 18 years
Exclusion Criteria:
- patients with a previous surgery on the affected kidney
- patients with a fully intrarenal/endophytic tumor without an exophytic component
- previous malignancy with ongoing or planned nephrotoxic chemotherapy
- current immunosuppression (e.g., organ transplantation, leukemia)
- pregnancy, lactation, or women who wish to have children
- inability to give informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN)
Time Frame: day of surgery
|
day of surgery
|
|
Correlation of HSI data with histopathological report
Time Frame: day of surgery
|
day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation of HSI data with demographic parameters
Time Frame: day of surgery
|
day of surgery
|
|
Correlation of HSI data and respective clamping technique with postoperative kidney function
Time Frame: from the day of surgery until discharge (up to 6 days)
|
from the day of surgery until discharge (up to 6 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Other Study ID Numbers
- RAPN-HSI-059/25-ck
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