Kidney NeoplasmHSI-RenalNCT07803315
Hyperspectral Imaging in Robot-Assisted Partial Nephrectomy
An observational study of Kidney Neoplasm and Renal Mass up to 7cm, run by University of Leipzig at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasm, Renal Mass up to 7cm
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants for the trial will be selected from all patients referred to the Department of Urology at the University Hospital Leipzig for undergoing partial nephrectomy.
Who may be able to join
- Patients with a kidney tumor ≤7cm
- planned robot-assisted partial nephrectomy
- age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jens-Uwe Stolzenburg, Professor Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Leipzig
Leipzig, 04103
Jens-Uwe Stolzenburg, Professor Dr., +49 3419717600, jens-uwe.stolzenburg@medizin.uni-leipzig.de
Doreen Trebst, Dr., +49 3419717610, doreen.trebst@medizin.uni-leipzig.de
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Kidney Neoplasm, Renal Mass up to 7cm
- Keywords
- Kidney Tumor, Partial Nephrectomy, Robotic Surgical Procedures, Minimally Invasive Surgical Procedures, Optical Imaging
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN)
Measured: day of surgery
Correlation of HSI data with histopathological report
Measured: day of surgery
Secondary outcomes (2)
Correlation of HSI data with demographic parameters
Measured: day of surgery
Correlation of HSI data and respective clamping technique with postoperative kidney function
Measured: from the day of surgery until discharge (up to 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens-Uwe Stolzenburg, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803315
- Sponsor's protocol ID
- RAPN-HSI-059/25-ck
- Acronym
- HSI-Renal
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Mapping and Tissue Characterization Using Hyperspectral Imaging in Robot-Assisted Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT07803315
- Acronym / sponsor ID
- HSI-Renal / RAPN-HSI-059/25-ck
- Conditions
- Kidney Neoplasm, Renal Mass up to 7cm
- Keywords
- Kidney Tumor, Partial Nephrectomy, Robotic Surgical Procedures, Minimally Invasive Surgical Procedures, Optical Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants for the trial will be selected from all patients referred to the Department of Urology at the University Hospital Leipzig for undergoing partial nephrectomy.
Key inclusion criteria (3 listed)
- Patients with a kidney tumor ≤7cm
- planned robot-assisted partial nephrectomy
- age ≥ 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN)
Time frame: day of surgery
Correlation of HSI data with histopathological report
Time frame: day of surgery
2 secondary outcomes
Correlation of HSI data with demographic parameters
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens-Uwe Stolzenburg, Professor Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasm and Renal Mass up to 7cm, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens-Uwe Stolzenburg, Professor Dr. (+49 3419717600, jens-uwe.stolzenburg@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN) (time frame: day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.