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Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Ovarian Cancer and Peritoneal Metastasis

9 avril 2015 mis à jour par: katrijn Michielsen, Universitaire Ziekenhuizen KU Leuven

Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the diagnosis is often been made in an advanced cancer stage with metastases throughout the peritoneum.

An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for the first time that patients in such an advanced stage of ovarian cancer who received first three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had fewer complications than patients treated with primary debulking surgery followed by chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most important prognostic marker appeared to be whether patients with primary or interval surgery no longer had a visible residual tumor after the treatment. Patients who had only small metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N Engl J Med 363 (1910): 943 - 953).

Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation where they assess which of the two treatments is the best option.

The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to assess which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.

Aperçu de l'étude

Statut

Complété

Description détaillée

BACKGROUND OF THE STUDY

Ovarian cancer is a gynecological cancer with a high risk of mortality. This is because the diagnosis is often been made in an advanced cancer stage with metastases throughout the peritoneum. The standard treatment for this condition till now consisted of primary debulking surgery where the tumor, the uterus and both the ovaries were removed, followed by a minimum of six treatments with platinum-based chemotherapy. This operation is often accompanied by serious complications such as for example bleedings, embolic events, infections and in extreme cases, even mortality. An international study led by Prof. Dr. Ignace Vergote (Gynaecological Oncology) showed for the first time that patients in such an advanced stage of ovarian cancer who received first three neoadjuvant platinum-based chemotherapy regimens followed by interval debulking surgery, and in turn followed by at least 3 treatment with platinum-based chemotherapy, had fewer complications than patients treated with primary debulking surgery followed by chemotherapy. Moreover, the final survival rate in both groups seemed to be similar. The most important prognostic marker appeared to be whether patients with primary or interval surgery no longer had a visible residual tumor after the treatment. Patients who had only small metastases in the peritoneum, seemed to be better treated with primary surgery (neoadjuvant Vergote I, et al Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Crystallising, N Engl J Med 363 (1910): 943 - 953).

Each patient with suspected advanced ovarian cancer should undergo a preoperative evaluation where they assess which of the two treatments is the best option. This should of course, for each individual patient, take into account comorbidity, cancer stage, number and location of the metastases etc. Currently,[18F] FDG-PET/CT, CT and conventional MRI are being used for staging, detecting recurrence and metastasis and for evaluating therapy response. These techniques have some disadvantages. A PET study takes a long time to perform and makes use of radioactive material. The addition of CT also gives rise to additional radiation. [18F] FDG accumulates in inflammatory cells in the tumor. This can explain the difficulties concerning early evaluation of treatment response. Although CT allows high resolution images of the entire body, sometimes the technology lacks sufficient sensitivity or specificity. Although conventional MRI has the highest sensitivity for detection of liver metastases, the lack of efficient whole-body imaging for staging a disadvantage when assessing systemic tumor spread and metastasis. Small peritoneal metastases are therefore often missed with this technique.

Diffusion-weighted imaging (DWI) is an emerging technology that is currently being uses in cancer imaging. Here the difference in movement of water molecules provides information about the integrity of cellular membranes. DWI has the advantage that no contrast material is required and there is also no need for exposure to ionizing radiation. Further developments in technology allowed for an acceptable time in whole body conducting research, so we should be able to image gastrointestinal tumors with this whole body technique.

AIM OF THE STUDY

The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to assess which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Leuven, Belgique, 3000
        • University Hospital Gasthuisberg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Patients diagnosed with stage IIIC or IV epithelial ovarian cancer in the presence of peritoneal metastasis are, on a voluntary basis, enrolled in the study. These are patients who 'll either underwent primary debulking surgery followed by at least six courses of platinum-based chemotherapy or patients who will be assigned to three courses of neoadjuvant platinum-based chemotherapy followed by interval debulking surgery, followed in turn by at least three courses of platinum-based chemotherapy.

Exclusion Criteria:

  • Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR < 30 ml/min).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Evaluation of WB-DWI as a noninvasive method to assess which kind of treatment fits best for a particular patient with ovarian cancer in the presence of peritoneal metastasis
Délai: 2011-2015 continuously
The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI)as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to evaluate which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.
2011-2015 continuously

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2011

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 décembre 2014

Dates d'inscription aux études

Première soumission

16 novembre 2010

Première soumission répondant aux critères de contrôle qualité

16 novembre 2010

Première publication (Estimation)

17 novembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

10 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 avril 2015

Dernière vérification

1 avril 2015

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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