Brief Title: INTROSPECT: Intraoperative PSMA PET/CT Imaging During Radical Prostatectomy (INTROSPECT)
INTROSPECT: INTRa-Operative PSMA-PET/CT for Radical Prostatectomy - A Pilot Study
During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the exact extent of the tumor. As a result, cancer cells may sometimes remain at the edge of the removed prostate, resulting in what is known as a positive surgical margin. Currently, positive surgical margins are identified by histopathology of the prostate specimen, with the results becoming available several days after surgery.
The long-term goal of intraoperative imaging is to provide surgeons with information about tumor extent and surgical margins while the operation is still ongoing. This information could allow surgeons to remove additional cancerous tissue during the same procedure while helping preserve surrounding healthy structures. This pilot study INTROSPECT is an initial step toward this goal.
INTROSPECT is a prospective pilot study at Geneva University Hospitals evaluating a PET/CT Scanner (AURA-10, Xeos Medical, Belgium) to analyze the prostate specimen directly in the operating room (results in 12 minutes). We plan to include 30 participants. They will all receive an injection of a radiotracer (gallium-68 PSMA-11) at the beginning of surgery. Images will be then compared to the microscopic evaluation to find out how accurately they show the location and extent of the cancer.
In this pilot study, the PET/CT findings will not be used to modify the surgical procedure or to remove additional tissue. The study is designed to determine whether the technique is sufficiently accurate and feasible to support future studies evaluating its use for real-time surgical decision-making.
The study will also assess radiation exposure to operating room personnel and explore methods for interpreting and segmenting the PET images.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Intraoperative Margin Assessment (IMA) in Robotic-Assisted Radical Prostatectomy (RARP) has the potential to reduce the 30% Positive Surgical Margin (PSM) rate.
Nevertheless, the leading technique, NeuroSAFE, is based on the Intraoperative Frozen section (IFS) of the lateral halves of the prostate, which, despite demonstrated oncological benefits comes with several drawbacks. First, implementation is largely restricted to specialized center as it requires dedicated pathology equipment (cryostat) and a uropathologist team trained to the technique. Secondly, apical and basal regions are not assessed therefore missing potential margins, frequently located in the apex. Finally, results are obtained in 45 minutes, potentially increasing operating time.
In this context intraoperative PSMA-PET margin assessment has been recently introduced using the CE-marked AURA-10 Device (Xeos Medical, Belgium) which can provide results within 12 minutes. Several previous studies confirmed the feasability of the procedure in the oncological settings. Regarding prostate cancer, only patients presenting high-risk prostate cancer were included, with a detection of 67% to 100% of PSM. Unfortunately, available evidence remains preliminary with several aspects requiring further investigation (population which can benefit of the technology, validation against histopathology, image interpretation [inter-reader agreement, segmentation methods] …). Also, clinical implementation requires a characterization of staff radiation exposure and residual specimen activity.
To address these questions, we designed INTROSPECT, a prospective IDEAL Stage 2a, single center, pilot study at Geneva University Hospitals. We aim to enroll 30 patients with intermediate or high-risk prostate cancer (PCa) scheduled for RARP. Eligibility requires uptake of the index lesion on preoperative PSMA PET imaging and an indication for radical prostatectomy after multidisciplinary Tumor Board presentation. Participants will undergo RARP with lymph node dissection when clinically indicated. The research procedures include intraoperative intravenous administration of gallium-68 PSMA-11 at 1.0 MBq/kg. The freshly resected prostate is placed in a dedicated holder and scanned in the operating room. The primary objective is to evaluate the concordance between ex-vivo PSMA and final histopathology. Secondary objectives include image interpretability evaluation and concordance with preoperative imaging modalities. We will also evaluate occupational exposure and residual specimen activity.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Canton of Geneva
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Geneva, Canton of Geneva, Svájc, 1205
- Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Diagnosis of intermediate- or high-risk prostate cancer.
- Preoperative PSMA PET staging with positive uptake in the primary tumor.
- Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion.
- Capacity to provide informed consent
Exclusion Criteria:
- Refusal to participate or withdrawal from the study.
- Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia.
- Participation in another clinical trial requiring ex vivo prostate tissue for research.
- Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy.
- Variant prostate cancer histology, such as neuroendocrine cancer.
- Insufficient-quality or unavailable PSMA PET images, including corrupted data, or an incomplete histopathology report.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Diagnosztikai
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Participants with prostate cancer undergoing robot-assisted radical prostatectomy.
Adult men with intermediate or high-risk prostate cancer with a PSMA -avid tumor (preoperative PET imaging) and a multidisciplinary indication for radical prostatectomy.
Reference Standard is the histopathological analysis.
No intraoperative re-resection is performed based on intraoperative results
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Single intravenous injection of 1.0 MBq/kg Gallium-PSMA, administered during surgery (docking phase).
PET/CT imaging of the freshly resected prostate specimen in the operating room using the AURA 10 device.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Concordance between ex vivo PSMA PET/CT imaging and histopathology
Időkeret: Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
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Concordance between intraoperative ex vivo PSMA PET/CT imaging and the final histopathological analysis/results of the prostate specimen including positive surgical margin assessment and lesion by lesion analysis (tumor extent).
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Day 0 (surgery) - From intravenous injection (Gallium PSMA), PET-PSMA, prostatectomy, through histopathological results (Day 10 post-surgery).
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Radiation exposure of operating room staff
Időkeret: Day 0 - prostatectomy
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Operating Room Staff (senior attending surgeon, fellow, scrub nurse, bedside assistant, circulating nurse, anaesthesiologist, installation technician) will wear Electronic Personal Dosimeter (DMC 3000™, Mirion Technologies, USA) to assess the Whole-Body Dose, Hp(10).
The bedside assistant will also wear an extremity dosimeter (ED3, Rotunda Scientific Technologies LLC, USA) to measure Hp(0.07).
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Day 0 - prostatectomy
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Radioactivity of the prostate specimen
Időkeret: Day 0 - protatectomy
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Residual specimen activity will be measured with a High-Purity Germanium Detector.
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Day 0 - protatectomy
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Concordance between in vivo and ex vivo imaging
Időkeret: From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
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Concordance in tumor localization and extent between preoperative imaging and intraoperative ex vivo PSMA PET/CT.
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From preoperative imaging (Day -180) to intraoperative ex vivo PSMA PET/CT (Day 1 post-surgery)
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Image interpretability and tumor segmentation
Időkeret: From intraoperative ex vivo PSMA PET/CT (Day 0 surgery ) to image interpretation (Day 0)
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Guidance for image interpretation, different tumour segmentation methods and inter-reader variability.
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From intraoperative ex vivo PSMA PET/CT (Day 0 surgery ) to image interpretation (Day 0)
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Massimo Valerio, Prof Dr med, Geneva University Hospitals (HUG)
Publikációk és hasznos linkek
Általános kiadványok
- Moraitis A, Kahl T, Kandziora J, Jentzen W, Kersting D, Pullen L, Reis H, Kollermann J, Kesch C, Krafft U, Hadaschik BA, Zaidi H, Herrmann K, Barbato F, Fendler WP, Darr C, Fragoso Costa P. Evaluation of Surgical Margins with Intraoperative PSMA PET/CT and Their Prognostic Value in Radical Prostatectomy. J Nucl Med. 2025 Mar 3;66(3):352-358. doi: 10.2967/jnumed.124.268719.
- Oderda M, Grimaldi S, Rovera G, Delsedime L, D'Agate D, Lavagno F, Marquis A, Marra G, Molinaro L, Deandreis D, Gontero P. Robot-assisted PSMA-radioguided Surgery to Assess Surgical Margins and Nodal Metastases in Prostate Cancer Patients: Report on Three Cases Using an Intraoperative PET-CT Specimen Imager. Urology. 2023 Dec;182:e257-e261. doi: 10.1016/j.urology.2023.08.013. Epub 2023 Sep 3.
- Darr C, Costa PF, Kahl T, Moraitis A, Engel J, Al-Nader M, Reis H, Kollermann J, Kesch C, Krafft U, Maurer T, Kohler D, Klutmann S, Falkenbach F, Kleesiek J, Fendler WP, Hadaschik BA, Herrmann K. Intraoperative Molecular Positron Emission Tomography Imaging for Intraoperative Assessment of Radical Prostatectomy Specimens. Eur Urol Open Sci. 2023 Jun 15;54:28-32. doi: 10.1016/j.euros.2023.05.017. eCollection 2023 Aug.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025-00458
- 2025 (Az Egyesült Államok NIH támogatása/szerződése: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Data will be shared only with researchers who also use the technology on a regular-basis during radical prostatectomy, provide a methodologically sound proposal, previously approved by an independent review board, in the context of multicentric collaboration only. Data will be provided only for analyses aiming at developping the technique.
Proposals should be directed to olivier.windisch@hug.ch
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ANALYTIC_CODE
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