NCT07803315

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Aug 2028

First Submitted

Initial submission to the registry

August 14, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 3, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

August 14, 2025

Last Update Submit

September 1, 2026

Conditions

Keywords

Kidney TumorPartial NephrectomyRobotic Surgical ProceduresMinimally Invasive Surgical ProceduresOptical Imaging

Outcome Measures

Primary Outcomes (2)

  • Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN)

    day of surgery

  • Correlation of HSI data with histopathological report

    day of surgery

Secondary Outcomes (2)

  • Correlation of HSI data with demographic parameters

    day of surgery

  • Correlation of HSI data and respective clamping technique with postoperative kidney function

    from the day of surgery until discharge (up to 6 days)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients with a kidney tumor ≤7cm
  • planned robot-assisted partial nephrectomy
  • age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leipzig

Leipzig, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jens-Uwe Stolzenburg

Study Record Dates

First Submitted

August 14, 2025

First Posted

September 3, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

September 3, 2026

Record last verified: 2026-09

Locations