Informations générales
  • Catégorie de maladie Cancer de la prostate (BASEC)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Lausanne
    (BASEC)
  • Responsable de l'étude NaïK Vietti Violi naik.vietti-violi@chuv.ch (BASEC)
  • Source(s) de données BASEC: Importé de 11.03.2025 ICTRP: N/A
  • Date de mise à jour 11.03.2025 16:25
HumRes65239 | SNCTP000005992 | BASEC2024-D0049

Comparison of prostate cancer screening between a standardized 3T MRI protocol and low field MRI: A prospective study.

  • Catégorie de maladie Cancer de la prostate (BASEC)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Lausanne
    (BASEC)
  • Responsable de l'étude NaïK Vietti Violi naik.vietti-violi@chuv.ch (BASEC)
  • Source(s) de données BASEC: Importé de 11.03.2025 ICTRP: N/A
  • Date de mise à jour 11.03.2025 16:25

Résumé de l'étude

This study aims to compare the effectiveness of low field MRI (0.55T) with traditional high field MRI (3T) in screening for prostate cancer and improving image quality. It is conducted in three phases: first, a pilot study with healthy volunteers to optimize the low field MRI protocol; then, an assessment of image quality between the two types of MRI in patients with metallic artifacts, particularly due to hip prostheses; finally, the evaluation of low field MRI in patients with suspicious prostate lesions on high field MRI (3T). Additionally, we will look back to study patients who underwent surgery for prostate cancer between 2018 and 2024. We will examine and measure the quality of prostate images taken no later than 6 months prior to surgery. We will also study the shape of the prostate in 3D and extract data from the images to better understand cancer. Our goal is to find an accessible solution for prostate cancer screening while maintaining or improving image quality.

(BASEC)

Intervention étudiée

MRI screening for prostate cancer.

(BASEC)

Maladie en cours d'investigation

Prostate cancer

(BASEC)

Critères de participation
Phase 2: Study of 0.55T MRI of the prostate in adult men with metallic implants. We include those whose 3T MRIs are deemed insufficient due to these implants. Phase 3: Evaluation of 0.55T MRI of the prostate in adult men with suspicious lesions. We include those whose 3T MRIs detected lesions classified as PI-RADS 4/5 and who are scheduled for targeted prostate biopsy. Phase 4: Comparison of imaging quality and radiomic data with a retrospective cohort. We include adult men who had prostate cancer and radical prostatectomy, and who underwent 3T MRI of the prostate prior to surgery. (BASEC)

Critères d'exclusion
Phase 2 and 3: - Any condition making the patient unsuitable for the study (contraindication to MRI). - Refusal to be informed in case of incidental findings on MRI. Phase 3: History of prostate cancer. Phase 4: Patients who underwent diagnostic 3T MRI of the prostate more than 6 months prior to surgery and 1.5T MRI of the prostate. (BASEC)

Lieu de l’étude

Lausanne

(BASEC)

non disponible

Sponsor

Prof. Ileana Jelescu

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

NaïK Vietti Violi

+41795560240

naik.vietti-violi@chuv.ch

Lausanne university hospital

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique du Vaud

(BASEC)

Date d'approbation du comité d'éthique

27.06.2024

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Comparing prostate cancer screening between standardized 3T MRI screening protocol and Low-Field MRI in a prospective study (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
non disponible

Intervention étudiée
non disponible

Type d'essai
non disponible

Plan de l'étude
non disponible

Critères d'inclusion/exclusion
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non disponible

Critères d'évaluation principaux et secondaires
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non disponible

Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible