- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jens-Uwe Stolzenburg, Professor Dr.
- Telefonnummer: +49 3419717600
- E-mail: jens-uwe.stolzenburg@medizin.uni-leipzig.de
Undersøgelse Kontakt Backup
- Navn: Doreen Trebst, Dr.
- Telefonnummer: +49 3419717610
- E-mail: doreen.trebst@medizin.uni-leipzig.de
Studiesteder
-
-
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Leipzig, Tyskland, 04103
- Rekruttering
- University Hospital Leipzig
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Kontakt:
- Jens-Uwe Stolzenburg, Professor Dr.
- Telefonnummer: +49 3419717600
- E-mail: jens-uwe.stolzenburg@medizin.uni-leipzig.de
-
Kontakt:
- Doreen Trebst, Dr.
- Telefonnummer: +49 3419717610
- E-mail: doreen.trebst@medizin.uni-leipzig.de
-
Ledende efterforsker:
- Jens-Uwe Stolzenburg, Prof. Dr.
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Ledende efterforsker:
- Doreen Trebst, Dr.
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Underforsker:
- Sigrun Holze, Dr.
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Underforsker:
- Clara Steiner, Dr.
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Correlation of hyperspectral imaging (HSI) data with clamping technique during robot-assisted partial nephrectomy (RAPN)
Tidsramme: day of surgery
|
day of surgery
|
|
Correlation of HSI data with histopathological report
Tidsramme: day of surgery
|
day of surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Correlation of HSI data with demographic parameters
Tidsramme: day of surgery
|
day of surgery
|
|
Correlation of HSI data and respective clamping technique with postoperative kidney function
Tidsramme: from the day of surgery until discharge (up to 6 days)
|
from the day of surgery until discharge (up to 6 days)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Karcinom
- Karcinom, nyrecelle
- Nyre-neoplasmer
Andre undersøgelses-id-numre
- RAPN-HSI-059/25-ck
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