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Completed

NCT Number: NCT01657747

Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer

The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for

* accurate staging of patient suspected having ovarian cancer * early treatment assessment * detecting tumor recurrence

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Key information

Conditions

Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals UZ Leuven, Gasthuisberg

Leuven, 3000, Belgium

About this study

  • Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner.
  • Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector.
  • Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • STAGING: patients with suspected ovarian carcinoma
  • EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
  • IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months

Exclusion criteria

  • patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
  • patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan

Treatment and study plan

Whole body diffusion-weighted MRI

Other

MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for this reason not eligible for the study.

During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.

During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines.

Other names: Dotarem, Buscopan

Primary outcomes

  1. Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study

    Time frame: Nov 2011 - Sep 2012 (up to 1 year)

    Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study

  2. WB-DWI for tumor characterization and staging at primary diagnosis

    Time frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)

    The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.

  3. WB-DWI for response assessment during and early after neoadjuvant chemotherapy

    Time frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)

    The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability

Secondary outcomes

  1. The prognostic value of DWI-determined imaging markers

    Time frame: Nov 2013 - Nov 2015 (expected) (up to 2 years)

    The aim of this part of the study is the determination of prognostic DWI-determined imaging and response markers towards patients disease free survival and overall survival.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: S53580

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2012
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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