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

Purpose

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

Condition	Intervention
Ovarian Carcinoma	Other: Whole body diffusion-weighted MRI

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Official Title:	Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Scopolamine Scopolamine hydrobromide Butylscopolamine bromide

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
WB-DWI for tumor characterization and staging at primary diagnosis [ Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years) ] [ Designated as safety issue: No ]
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.
WB-DWI for response assessment during and early after neoadjuvant chemotherapy [ Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years) ] [ Designated as safety issue: No ]
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 Outcome Measures:

The prognostic value of DWI-determined imaging markers [ Time Frame: Nov 2013 - Nov 2015 (expected) (up to 2 years) ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	200
Study Start Date:	November 2011
Estimated Study Completion Date:	August 2016
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657747

Contacts

Contact: Katrijn Michielsen, Master in Biomedical Sciences	+32 16 34 90 76	katrijn.michielsen@med.kuleuven.be
Contact: Ilse Roebben, Master in Biomedical Sciences	+32 16 34 90 74	ilse.roebben@uzleuven.be

Locations

Belgium
University Hospitals UZ Leuven, Gasthuisberg	Recruiting
Leuven, Belgium, 3000
Contact: Vincent Vandecaveye, MD, PhD +32 16 34 05 18 vincent.vandecaveye@uzleuven.be
Contact: Katrijn Michielsen, Master in Biomedical Sciences +32 16 34 90 76 katrijn.michielsen@med.kuleuven.be
Principal Investigator: Vincent Vandecaveye, MD, PhD

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:

Vincent Vandecaveye, MD, PhD

UZ Leuven

More Information

No publications provided

Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01657747 History of Changes
Other Study ID Numbers:	S53580
Study First Received:	November 2, 2011
Last Updated:	August 3, 2012
Health Authority:	Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:

Ovarian carcinoma
Staging
Early treatment follow-up
Identifying tumor recurrence
Whole body diffusion-weighted MRI

Additional relevant MeSH terms:

Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Recurrence
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases

Gonadal Disorders
Disease Attributes
Pathologic Processes
Butylscopolammonium Bromide
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013

Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer (S53580)